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warningsine · 2 years ago

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A team of researchers in the United States and United Kingdom say they have created the world’s first synthetic human embryo-like structures from stem cells, bypassing the need for eggs and sperm.

These embryo-like structures are at the very earliest stages of human development: They don’t have a beating heart or a brain, for example. But scientists say they could one day help advance the understanding of genetic diseases or the causes of miscarriages.

The research raises critical legal and ethical questions, and many countries, including the US, don’t have laws governing the creation or treatment of synthetic embryos.

The pace of discoveries in this field and the growing sophistication of these models have alarmed bioethics experts as they push ever closer to the edge of life.

“Unlike human embryos arising from in vitro fertilization (IVF), where there is an established legal framework, there are currently no clear regulations governing stem cell derived models of human embryos. There is an urgent need for regulations to provide a framework for the creation and use of stem cell derived models of human embryos,” James Briscoe, associate research director at the Francis Crick Institute, said in a statement.

Dr. Magdalena Zernicka-Goetz described the work in a presentation Wednesday to the International Society for Stem Cell Research’s annual meeting in Boston. Zernicka-Goetz, a professor of biology and biological engineering at CalTech and the University of Cambridge, said the research has been accepted at a well-regarded scientific journal but has not been published. The research was first reported by The Guardian.

Zernicka-Goetz and her team, along with a rival team in Israel, had previously described creating model embryo-like structures from mouse stem cells. Those ��embryoids” showed the beginnings of a brain, heart and intestinal tract after about eight days of development.

The embryo-like structures that Zernicka-Goetz says her lab has created were grown from single human embryonic stem cells that were coaxed to develop into three distinct tissue layers, she said. They include cells that would typically go on to develop a yolk sac, a placenta and the embryo itself.

She told CNN that the embryo-like structures her lab has created are also the first to have germ cells that would go on to develop into egg and sperm.

“I just wish to stress that they are not human embryos,” Zernicka-Goetz said. “They are embryo models, but they are very exciting because they are very looking similar to human embryos and very important path towards discovery of why so many pregnancies fail, as the majority of the pregnancies fail around the time of the development at which we build these embryo-like structures.”

She said that to her knowledge, it was the first time a human model embryo had been created with three tissue layers. But she stressed that while it mimics some of the features of a natural embryo, it doesn’t have all of them.

Researchers hope these model embryos will shed light on the “black box” of human development, the period following 14 days after fertilization, which is the agreed limit for scientists to grow and study embryos in a lab.

Right now, the synthetic model human embryos are confined to test tubes. It would be illegal to implant one in a womb, and animal research with stem cells from mice and monkeys has shown that even when scientists have attempted to implant them, they don’t survive – probably because researchers haven’t figured out how to fully replicate the conditions of pregnancy.

Zernicka-Goetz said that the aim of her research wasn’t to create life but to prevent its loss, understanding why embryos sometime fail to develop after fertilization and implantation.

“We know remarkably little about this step in human development, but it is a time where many pregnancies are lost, especially in an IVF setting,” Roger Sturmey, senior research fellow in maternal and fetal health at the University of Manchester in the UK, said in a statement.

“Currently, we can say that these ‘synthetic embryos’ share a number of features with blastocysts, but it is important to recognise that the way that synthetic embryos are formed is different to what happens when a normal embryo forms a blastocyst,” he said. “There is much work to be done to determine the similarities and differences between synthetic embryos and embryos that form from the union of an egg and a sperm.”

#Magdalena Żernicka Goetz #synthetic embryo #news #stem cells

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algeroth · 8 years ago

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As biological research races forward, ethical quandaries are piling up. In a report published Tuesday in the journal eLife, researchers at Harvard Medical School said it was time to ponder a startling new prospect: synthetic embryos.

In recent years, scientists have moved beyond in vitro fertilization. They are starting to assemble stem cells that can organize themselves into embryolike structures.

Soon, experts predict, they will learn how to engineer these cells into new kinds of tissues and organs. Eventually, they may take on features of a mature human being.

In the report, John D. Aach and his colleagues explored the ethics of creating what they call “synthetic human entities with embryolike features” — Sheefs, for short. For now, the most advanced Sheefs are very simple assemblies of cells.

But in the future, they may develop into far more complex forms, the researchers said, such as a beating human heart connected to a rudimentary brain, all created from stem cells. Such a Sheef might reveal important clues about how nerves control heartbeats.

Whatever else, it is sure to unnerve most of us.

Established guidelines for human embryo research are useless for deciding which Sheefs will be acceptable and which not, Dr. Aach argued. Before scientists get too deeply into making Sheefs, some rules must be put in place.

#biology #bioethics #embryology #synthetic human #tissue engineering #sheef totally doesn't sound like something from a bad scifi that will wipe out the humanity

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ezatluba · 3 years ago

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Creation of First Human-Monkey Embryos Sparks Concern

Called chimeras, these lab-grown creations have been hailed as a major scientific breakthrough. But some ethics experts see reason for worry

An image of the first monkey-human embryo shows human cells, tagged in red, in a macaque monkey embryo three days after researchers inserted human stem cells.

By Robert Lee Hotz

April 26, 2021

Imagine pigs with human hearts or mice whose brains have a spark of human intelligence. Scientists are cultivating a flock of such experimental creations, called chimeras, by injecting potent human cells into mice, rats, pigs and cows. They hope the new combinations might one day be used to grow human organs for transplants, study human illnesses or to test new drugs.

In the latest advance, researchers in the U.S. and China announced earlier this month that they made embryos that combined human and monkey cells for the first time. So far, these human-monkey chimeras (pronounced ky-meer-uhs) are no more than bundles of budding cells in a lab dish, but the implications are far-reaching, ethics experts say. The use of primates so closely related to humans raises concerns about unintended consequences, animal welfare and the moral status of hybrid embryos, even if the scientific value of the work may be quite high.

“There were lots of breakthroughs in this experiment,” says bioethicist Nita Farahany of Duke University. “A remarkable step has been taken scientifically that raises urgent issues of public concern. We need to figure out what the right pathway forward is to help guide responsible progress.”

Scientists have been creating partly human chimeras for years. Researchers use rats with human tumors to study cancer, for example, and mice with human immune systems to conduct AIDS research. What makes the latest experiment unique is that the scientists injected human stem cells, which can become any kind of tissue, into an embryo of a closely related primate.

To make them, researchers from the Salk Institute for Biological Studies in La Jolla, Calif., and China’s Kunming University of Science and Technology injected human stem cells—made by reprogramming mature skin or blood cells—into 132 embryos from macaque monkeys. Six days after the monkey embryos had been created at the State Key Laboratory of Primate Biomedical Research in Kunming, researchers injected each one with 25 human stem cells labeled with a fluorescent red protein.

“We put them together in a petri dish in the laboratory, to see how they interact with one another,” says Juan Carlos Izpisua Belmonte, director of the Salk gene expression laboratory, who led the research effort. The next day, the monkey embryos glowed. Human cells had become integrated into all of them, far more effectively than in previous experiments with embryos from other species such as pigs, they reported on April 15 in Cell.

So far, these human-monkey chimeras can’t survive longer than 19 days. “It’s never been our intention and never will be to create a living chimera in a monkey host,” says Dr. Izpisua Belmonte.

Even so, the new chimera experiment highlights a dilemma. When human stem cells are injected into an animal embryo at such an early stage of development, there so far is no way to control where they go or limit what type of adult cells they become, other scientists say.

“It does show that the human stem cells tend to migrate far and wide through the monkey embryo,” says Insoo Hyun, a bioethicist at Case Western Reserve University in Cleveland, who is involved in international oversight of such research. “That is what leads to the theoretical concern: There is a chance that in an uncontrolled way it may lead to a mixing of human cells that may result in human cells developing in the brain or the heart or from head to toe across the body.” That means researchers can’t target the stem cells to create specific organs or avoid random changes to the animal’s brain—at least not yet.

In a glimpse of the potential effects, researchers at the University of Rochester in 2014 transplanted human fetal brain cells called astrocytes into young laboratory mice. They discovered that within a year the human cells had taken over the mouse brains. Moreover, standard tests for mouse memory and cognition showed that the altered mice were smarter.

In such ways, stem-cell chimeras have “the potential to radically humanize the biology of laboratory animals,” Dr. Hyun says.

It has long been a politically charged field of research, bioethicist Henry Greely at Stanford University says. In his 2006 State of the Union Address, President George W. Bush called the creation of human-animal hybrids one of “the most egregious abuses of medical research.” Seven countries ban or restrict it. Since 2015, the U.S. National Institutes of Health has refused to fund experiments that involve human stem cells added to early animal embryos.

Policy makers, however, might relax some restrictions this year. An NIH spokeswoman says that the organization is awaiting the release next month of updated guidelines from the International Society for Stem Cell Research “to ensure our position reflects the input from the community, which has been very thoughtful.” The agency lifted restrictions on fetal-tissue research earlier this month.

“I believe that NIH is eager to move on,” says Dr. Hyun, who led the committee that updated the society’s guidelines for experiments involving human-primate chimeras.

Dr. Izpisua Belmonte says he welcomes oversight. At his urging, the recent experiment was reviewed beforehand not just by institutional review boards in the U.S. and China but also by three independent bioethics experts. “Not everything that we scientists can do should be done,” he says. “Experiments like this certainly raise many concerns.”

Are such experiments worth doing to advance scientific research? Or do ethical concerns outweigh the benefits? Join the conversation below.

Research using primates is increasingly difficult in Europe and the U.S. The Salk team collaborated with scientists in China to take advantage of their growing expertise in keeping monkey embryos alive outside the body. China singled out the creation of primate disease models as a national goal in 2011, aiming to create gene-altered monkeys suitable for studying treatments or cures for a variety of human brain diseases and disorders such as autism.

While major technical hurdles remain, scientists in China already are using tools of embryo engineering, such as cloning, to speed up the breeding of primates given new traits through modern gene-editing techniques.

“As long as it is an embryo in a dish we are not concerned,” Dr. Greely says of the human-monkey chimera. “If you actually try to gestate such a thing, particularly if you can bring it successfully to term, then the issues get more significant.”

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dpu-pune-blog · 7 years ago

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Build your Career with Biotech

Biotechnology is the use of living systems and organisms to develop or make products, or "any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use".

Biotechnology is the industrial and pharmaceutical application of cell and molecular biology. Our greatest advantage is India's biodiversity and a large pool of young scientists with a strong base in physics, chemistry, biology, computation and mathematical sciences.

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The B. Tech Biotechnology course has eight semesters & M. Tech (Integrated) Biotechnology course has ten semesters. The Syllabus covers basic subjects as: Physics, Chemistry, Basic Biology, Biomathematics & Biostatistics, Microbiology, Biochemistry, Cell Biology, Engineering Courses, Plant & Mammalian Physiology, Molecular Biology, Genetics & Immunology. Advanced Biotechnology subjects as: Genetic Engineering, Pharmacology & Toxicology, Biopharmaceuticals, Fermentation Technology, r-DNA Technology, Food, Environmental Biotechnology, Industrial Biotechnology, Bioprocess Engineering, Animal & Plant Tissue Culture, Quality Control Management, Computer Courses such as : Functional Bioinformatics, Structural Bioinformatics, Drug Designing, Protein Modeling, Genomics, Proteomics, etc. The B. Tech Medical Biotechnology course has eight semesters. It covers Physics, basic sciences subjects as: Cell Biology, Mathematics, and Bimolecular & Organic Chemistry. Medical Related Subjects as: Medical Biochemistry, Microbiology and Virology, Human Anatomy & Physiology, Pharmacology & Toxicology, Cancer Biology, Human Genetics, Biopharmaceuticals, Epidemiology and Developmental Biology. Medical Technology Related Subjects as: Analytical Techniques, Molecular Biology, Immunology, Genetic Engineering, Animal Cell Culture, Bioprocess Engineering, Tissue Engineering & Transplantation, Forensic Science, Nano medicine, Biosensors & artificial organs. Engineering Subjects as: Electronic and Instrumentation, Introduction to Computers & Computer Application, Biomedical Instrumentation and Biomedical devices. Medical Informatics Related subjects as: Bioinformatics, Molecular Modeling and Drug Designing, Genomics, Transcriptomics and Proteomics, Metabolic Engineering and System Biology. Humanity Courses as: Communication Skills, Environmental Sciences, Biosafety, Bioethics & IPR and Hospital Management. Elective Courses as: Group 1: Clinical Research, Group 2: Molecular Medicine and Cancer Research, Group 3. Vaccine and Drug Development, Group 4. Advanced Medicine etc., The students will also study subjects like: Communications Skills, Technical Writing, and Scope of Biotechnology in Business, Bioethics, Biosafety, IPR etc., for development of his/her personality and make him/her ready for the industry and research. The integrated M. Tech course in Biotechnology trains students essentially for Research & Development in Biotech Industry. For this the last semester of B. Tech courses and last two semesters of M. Tech course are set aside for industrial training and / or research training.

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Biotechnology combines genetics, biochemistry, microbiology, immunology, fermentation technology, bioprocess engineering, tissue culture technology, molecular biology and recombinant DNA technology. Biotechnology has applications in the production of medical and veterinary products, chemicals, food, drugs and pharmaceuticals, diagnostics, blood products, artificial organs, nutraceuticals, etc. and in the fields of chemical engineering, energy, pollution control, environment protection and waste management. Industrial units in these fields need personnel skilled and trained in biotechnology.

Medical Biotechnology and the opportunities, it offers:

Medical Biotechnology combines genetics, biochemistry, microbiology, immunology, bioprocess engineering, tissue culture technology, molecular biology and recombinant DNA technology that is required to develop new drugs, diagnostic kits, alternate therapeutics, understanding disease and its pathways. Medical Biotechnology has applications in the production of medical products, drugs, vaccines, diagnostics kits, pharmaceuticals, blood products, artificial organs, nutraceuticals, etc. and in the fields of clinical research, drug discovery, epidemiology, cancer and AIDS research, regenerative medicine, forensic science, gene therapy, genetic counseling, eugenics.

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Eligibility for NRI / PIO / FN :

· A candidate in any of these categories shall have completed 17 years of age on or before 31st December 2017 (having born before 1st January 2001). He/she must have Physics, Chemistry, Biology or Life Sciences and English (and desirably Mathematics) at the CBSE, ISC, HSC or an equivalent examination. In the case of a student from any school that follows the American system of education, the candidate must have studied Physics, Chemistry and Biology (and desirably Mathematics) at AP' (Advanced Placement) level and must have minimum 'C' grade in these subjects. In the case of students passing Cambridge International Examination (CIE) the candidate should have passed Physics, Chemistry and Biology at “Advanced” level along with English at “Advanced Subsidiary” (AS) level.

For more info pls visit us on: http://biotech.dpu.edu.in/

#Biotech #B.Tech #DPU #MedicalBiotechnology #M.Tech(Integrated)Biotechnology

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aburameshin · 6 years ago

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Stem cells

Stem cells have the ability to transform into any cell in the body, so they can replicate several times, unlike other cells in the body. This type of cell can be found in embryonic cells and in various parts of the body, for example in the blood, placenta, umbilical cord, bone marrow, among others. In addition, this capacity for renewal that occurs through cell division can occur in an induced way in stem cells after periods of inactivity. In this way, genetic engineering studies have advanced a lot, as scientists are betting on the manipulation of stem cells for therapeutic purposes, healing and treatment of certain degenerative and chronic diseases, trauma and recovery of damaged tissues.

Types

There are three major groups of stem cells: embryonic, non-embryonic or adult and induced.

- Embryonic stem cells

Embryonic stem cells, as the name says, are those found in embryos, approximately 5 days after fertilization . That is, they form at the beginning of embryonic development . These types of stem cells stand out by the process called "cell differentiation", since they have high capacity to transform into any type of cell, thus generating specialized cells and different tissues of the body.

Embryonic stem cells are classified into:

Totipotent stem cells: which generate extra-embryonic tissues giving rise to complete organisms. They can differentiate into all tissues in the human body. An example is the zygote.

Pluripotent change cells : specialized in generating cells of the three embryonic leaflets (ectoderm, mesoderm and endoderm). Thus, they can transform into almost all tissues of the body, except placenta and embryonic attachments.

- Adult stem cells

Adult stem cells are undifferentiated cells that have the function of renewing and repairing body tissues. However, they are less versatile than embryonic stem cells. Thus, in relation to embryonic stem cells, adult cells are not derived from embryonic tissues and have the capacity to transform on a smaller scale Adult stem cells are found in all parts of the human body, especially in bone marrow and umbilical cord blood, and are taken from the patients for medical purposes. In other words, adult stem cells are more difficult to divide than embryonic stem cells, so current research largely uses embryonic stem cells to produce embryonic stem cells.

- Induced stem cells

The induced stem cells are those produced in the laboratory, the first were produced from skin cells in 2007. After some testing, it was proven that these cells could differentiate in the three embryonic leaflets. Thus, they are withdrawn from an adult individual, which lessens some of the bioethical conflicts of stem cell use by excluding the use of embryos. These cells represent the possibility of treating some types of diseases, since they represent the possibility of reconstruction of tissues and organs.

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arcticdementor · 4 years ago

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Oxford University panjandrum and philosopher Julian Savulescu has spent most of his career advancing positions that push the envelope of acceptable medical practice. He has told us, for instance, that we are morally obligated to genetically engineer our babies under a principle he terms “procreative beneficence.” His efforts often strike one as having the seeming intent of giving the IVF and biotechnology industries cover under a supposedly ethical flag. No surprise, then, to find him advocating for us to engage in “extreme altruism” in the time of COVID-19.

In a recent post on the Practical Ethics blog with co-author Dominic Wilkinson, also at the Oxford Uehiro Centre for Practical Ethics, Savulescu argues in favor of allowing (or even perhaps encouraging) acts of extreme altruism in the time of coronavirus. The response to the pandemic has already revealed some unsettling realities about how we differentially value lives, with politicians and others directing medical and fiscal resources toward the young , the white, and the well-to-do, as Black , indigenous , and people of color, or those with disabilities are shortchanged. The argument Savulescu and Wilkinson make is thus all the more disquieting as a rationalization for such actions.

…

All this breezy offering up of patients’ lives is highly problematic. In cases 1 and 4, the authors say participants might benefit, which is a bit of a stretch, given that they also might be hurt or killed; in cases 2 and 3, patients are on death’s door and stand to profit not at all from having tissues or organs taken from them, while they forgo any chance, however slight, of recovery.

…

As for mustering nursing home residents to the fight against COVID-19, the scheme bears more than a whiff of Vernichtung lebensunwerten Lebens, the Nazi program of destroying “lives unworthy of life.” This widespread euthanization effort predated the death camps and targeted institutionalized Germans, including frail or physically impaired older people and those with disabilities and chronic ailments.

Bizarrely, the authors imply that we perpetrate a kind of ageism in preventing nursing home residents from volunteering for risky medical experiments given “that challenge studies using the SARS-COV2 virus (which causes COVID-19) would be ethical […] in healthy young adults.” Why, then, shouldn’t those in nursing or care facilities have the same option?

…

In the end, one wonders why the authors even bothered to assemble their argument, as it seems difficult to imagine how such extreme altruism would play out. Who, actually, will be tasked with evaluating whether a person in a care facility genuinely understands what they are agreeing to when they volunteer out of an excess of care for their fellow human beings or in a desire to advance scientific understanding? Is someone sedated heavily on a ventilator capable of assessing whether they should allow their organs to be harvested in advance of their death? Does it seem likely that healthcare workers who have made a yeoman’s effort to save a patient’s life would voluntarily switch gears at the last minute to offer them the chance to serve as experimental fodder?

Savulescu and Wilkinson opine that “…there is a constant national emergency: we are all aging and slowly dying. There is a war against aging and death: we are fighting it with medicine. And people should be able [to] sacrifice their interests or lives in this war.” The use of this militaristic language obscures the fact that aging and dying are inevitabilities that medicine cannot ultimately address. Especially in a time of pandemic, we need to be especially clear about making false promises in that regard. Certainly, we should not be deploying rhetorical claptrap based on tired tropes to justify using vulnerable populations as sacrificial victims.

#center for genetics and society #covid19 #eugenics #gina maranto #julian savulescu

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nevamwitti · 5 years ago

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More ‘Buyer Beware’ Warnings for Unregulated Stem Cell Clinics

THURSDAY, Aug. 1, 2019 (HealthDay News) — Folks who get treatment from a stem cell clinic could be spending their money on what amounts to snake oil, a new study warns.

Doctors administering stem cells might have no expertise in the condition they’re trying to treat, and the cells themselves might be derived from questionable or discredited sources — if the treatment contains any stem cells at all.

“The stem cell treatments offered by these clinics have not been through the [U.S. Food and Drug Administration] approval process, so their safety and efficacy has not been systematically tested or documented. It’s a ‘buyer beware’ situation,” said lead researcher Emma Frow. She is an assistant professor of biological and health systems engineering at Arizona State University in Tempe.

“Also, these treatments are usually not reimbursed by insurance companies, so consumers have to pay out of pocket,” she said.

Dodgy stem cell treatments can be dangerous. Three people have been blinded by stem cell injections intended to treat their macular degeneration, Frow said, while other cases have raised cancer concerns.

In November, the FDA issued a warning letter to San Diego-based Genetech after a dozen patients in three states were hospitalized with serious bacterial infections after receiving injections of umbilical cord blood purportedly containing stem cells. The products were tainted with E. coli and other dangerous bacteria.

A variety of ailments … and workers

Frow and colleagues identified 169 stem cell clinics in the southwestern United States. They catalogued the treatments being offered and the medical personnel staffing each center.

About a quarter of the clinics focused only on stem cell treatments.

“For the other 75%, stem cell treatments are one among some or many different possible treatment options at the clinic — for example, a sports medicine clinic that lists stem cells as just one among a whole roster of different treatment options for sports injuries,” Frow said.

The study showed that stem cell clinics are operated by a wide variety of health care workers.

Nearly three-quarters of employees at clinics that focus solely on stem cells are doctors with either an M.D. or D.O. degree, researchers said.

They found that 14% of employees were either chiropractors or naturopaths; 7% had some other medical qualification; 5% had a graduate degree; and 2% had unspecified qualifications.

But even fully credentialed doctors might not be specialists in the conditions that their clinics promise to treat, researchers said.

“Specialists in orthopedics and sports medicine are more likely to restrict stem cell treatments to conditions related to their medical specialties, while care providers with specialties in cosmetic or alternative medicine are more likely to treat a much wider range of conditions with stem cells,” Frow said.

Providers administering stem cells had a wide range of specialties, including family practice, internal medicine, anesthesiology, general surgery, cosmetic surgery, dermatology, sports medicine, acupuncture and herbal medicine.

Fat tissue was the stated source of stem cells for nearly two-thirds of the clinics, according to the study. Fat-derived stem cells were used to treat a wide range of illnesses, including neurodegenerative disorders, heart problems, gastrointestinal complaints, diabetes and muscular dystrophy.

Treatments derived from fat tissue may need FDA approval, and none has been granted, researchers said.

“Most of the businesses we profiled are likely not offering treatments that consist of pure stem cell preparations,” Frow said. “The clinics usually don’t make much information available on their websites, but the typical methods they mention for extracting and preparing the most common types of treatments on offer don’t result in pure preparations of stem cells.”

Watch for ‘cure-all’ claims

If you’re interested in stem cell therapy, pass on clinics that promote the treatments as a wonder drug, experts advised.

“If you see a business marketing stem cell treatments for 30 or 40 or 50 diseases, that’s eyebrow-raising,” said Leigh Turner, an associate professor at the University of Minnesota Center for Bioethics in Minneapolis. “If you see someone who’s been practicing for years as a cosmetic surgeon claiming to treat ALS or spinal cord injuries, it’s highly unlikely they’ve got something meaningful to offer.”

Frow offered a series of questions that people considering stem cell treatment can ask:

How many different conditions does the clinic offer to treat with stem cells?

Is the clinic participating in a formal, registered clinical trial using stem cells to treat your specific condition? (If so, you should not have to pay out of pocket for the treatment.)

Does the medical expertise of the doctor fit well with the specific condition for which you are seeking treatment?

Unfortunately, stem cell clinics wield flashy marketing featuring personal testimonials aimed at desperate people who suffer from chronic and incurable conditions, said Turner, who wasn’t involved with the study.

“People who are desperate or family members of someone who is ill or injured, they’re looking for messages that there are treatments out there,” he said.

The FDA has been saying for years that it plans to become actively engaged in regulation of stem cell clinics, but Turner isn’t holding out hope.

“When you think about how many hundreds of businesses are operating in the United States, there is this question of are we really going to ever see a day where this marketplace comes under meaningful regulatory control?” he said. “As someone who’s spent a long time looking at this, I’m not sure that day is going to come.”

The new study appears in the Aug. 13 issue of the journal Stem Cell Reports.

More information

The U.S. Food and Drug Administration has more about stem cell therapies.

The post More ‘Buyer Beware’ Warnings for Unregulated Stem Cell Clinics appeared first on Be Healthy News.

More ‘Buyer Beware’ Warnings for Unregulated Stem Cell Clinics posted first on https://www.behealthynews.com

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jerrytackettca · 6 years ago

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Genetic Editing of Animals Has Horrible Side Effects

Would you eat a burger made from a cow with lab-altered DNA? How about a potato or a piece of salmon that was similarly tweaked? Gene-editing technologies are here, and they're already being used to alter the food supply.

For instance, gene-edited crops, in which DNA is tweaked or snipped out at a precise location, include soybeans with altered fatty acid profiles, potatoes that take longer to turn brown and potatoes that remain fresher longer and do not produce carcinogens when fried.

Genetically engineered (GE) salmon, dubbed “frankenfish,” which are engineered to grow about twice as fast as typical farm-raised salmon, not only exist but are already being sold and eaten in Canada, to the tune of 5 tons in 2017 alone (none of which was labeled as such).1

The next step that biotech companies are racing to bring to the not-so-proverbial table is gene-edited farm animals. Unlike GE foods, which may have genes from other species inserted, gene editing involves altering an organism's DNA. Like GE foods, however, gene-edited foods come with unknown risks to the animals and the people who eat them.

Gene Editing Led to Enlarged Tongues, Extra Vertebrae and Other Side Effects

While scientists have made great strides in mapping out genomes of entire organisms, much remains unknown about the purpose of individual genes and how they interact with one another. As such, making tweaks to genes, even those intended to be precise, often lead to surprising and unintended consequences.

In the case of livestock, researchers have used CRISPR-Cas9 and other gene-editing technologies to create cows that can tolerate warmer temperatures (so they can be raised in the tropics), goats with longer cashmere wool and rabbits and pigs with bigger, leaner muscles. Serious side effects resulted, however, including enlarged tongues in the rabbits.2,3

Among pigs that were altered by deleting the myostatin (MSTN) gene, which limits muscle growth, the larger muscles came along with an extra vertebra in 20 percent of the gene-edited animals.

“This result provides us a new insight to better understand MSTN’s function in both skeletal and muscle formation and development in the future studies,” the researchers noted, adding, “This phenomenon has never been reported in other MSTN-mutant animals."4 And therein lies the problem.

Genetic tweaking is not an exact science, and often researchers don’t know the extent of a gene’s functions until something like an extra vertebra reveals itself. Lisa Moses, an animal bioethicist at Harvard Medical School’s Center for Bioethics, told The Wall Street Journal:5

"Humans have a very long history of messing around in nature with all kinds of unintended consequences … It's really hubris of us to assume that we know what we're doing and that we can predict what kinds of bad things can happen."

Gene Editing Is Being Used to Alter Physical Traits, Puberty and Diseases in Animals

Along with altering DNA to create meatier or more temperature-tolerant animals, researchers have snipped out a section of pig DNA intended to prevent Porcine Reproductive and Respiratory Syndrome (PRRS) — a common and often fatal ailment among CAFO (concentrated animal feeding operation) pigs.6 Such edits are permanent and passed down to other generations.

In another project, this one funded by the U.S. Department of Agriculture, researchers have added the SRY gene to cattle, which results in female cows that turn into males, complete with larger muscles, a penis and testicles, but no ability to make sperm.7 Male (or male-like) cattle are more valuable to the beef industry because they get bigger, faster, allowing companies to make greater profits in less time.

Other biotech companies have taken to targeting genes intended to ease animal suffering, which they believe may soften regulators and consumers who are wary of the technology. "It's a better story to tell," Tammy Lee, CEO of Recombinetics, told the New York Post.8

The company has snipped out the genes responsible for growing horns in dairy cows, for instance, which means they wouldn't be subjected to the inhumane ways the horns are currently removed (with no pain relief).

Currently, cows born with the hornless trait are being raised at the University of California, Davis, with plans to eventually test their milk for any oddities. The company is also working on editing genes so pigs don't go through puberty. This would make castrating pigs — an inhumane procedure currently done (also without painkillers) to prevent meat from gaining an unpleasant odor — unnecessary.9

Recombinetics and other biotech companies don't want gene-edited foods to come with any warnings or additional regulations, which could hamper the technology's progress and acceptance by farmers. Once this occurs, though, it's likely that gene-editing will be used less for humanity's sake and more to create larger profits, such as via gene-editing to increase litter size.10

What Are the Consequences of Eating Gene-Edited Foods?

Foods produced via gene-editing are not subject to regulation by the U.S. Department of Agriculture (USDA) — although an advisory board recommended gene-edited foods could not be labeled organic — or other regulatory agencies.11

In fact, in March 2018, the USDA released a statement noting that it would not regulate CRISPR-edited crops, noting, "With this approach, USDA seeks to allow innovation when there is no risk present."12

Gene editing, with its loose regulation, accessibility and quick results, has been called the next "food revolution,"13 at least for plant foods, but it's unclear whether the same will hold true for animals. In the U.S., it's been proposed that gene-edited foods do not need to be labeled, either, but the European Union ruled that they should be regulated the same as genetically modified organisms (GMOs).

Jaydee Hanson, an analyst at advocacy group the Center for Food Safety, told National Geographic that this may be closer to reality. "This is the new kind of genetic engineering, whether you call it transgenic [GMO] or not. It should be adequately regulated. We're not saying it should be stopped — we should know what has been done."14

As for what the health effects of eating gene-edited foods may be, no one knows. In an interview with GM Watch, Michael Antoniou, a London-based molecular geneticist, explained that significant changes could occur due to genetic editing, in both agricultural and medical contexts, necessitating long-term safety and toxicity studies. He explained:15

"Many of the genome editing-induced off-target mutations, as well as those induced by the tissue culture, will no doubt be benign in terms of effects on gene function. However, many will not be benign and their effects can carry through to the final marketed product, whether it be plant or animal …

Thus not only is it necessary to conduct whole genome sequencing to identify all off-target mutations from CRISPR-based genome editing, but it is also essential to ascertain the effects of these unintended changes on global patterns of gene function.

… In addition, it is important to acknowledge that the targeted intended change in a given gene may also have unintended effects. For example, the total disruption or modification of an enzyme function can lead to unexpected or unpredictable biochemical side-reactions that can markedly alter the composition of an organism, such as a food crop.

The compositional alterations in food products produced with genome editing techniques will not be fully revealed by the molecular profiling methods due to the current inherent limitations of these techniques. So it is still necessary to conduct long-term toxicity studies in established animal model systems. In the absence of these analyses, to claim that genome editing is precise and predictable is based on faith rather than science."

Gene Editing May Not Be as Precise as It Seems

Researchers at the U.K.'s Wellcome Sanger Institute systematically studied mutations from CRISPR-Cas9 in mouse and human cells, focusing on the gene-editing target site. Large genetic rearrangements were observed, including DNA deletions and insertions, that were spotted near the target site.

They were far enough away, however, that standard tests looking for CRISPR-related DNA damage would miss them. The DNA deletions could end up activating genes that should stay "off," such as cancer-causing genes, as well as silencing those that should be "on."16

CRISPR-Cas9 also leads to the activation of the p53 gene, which works to either repair the DNA break or kill off the CRISPR-edited cell.17 CRISPR actually has a low efficacy rate for this reason, and CRISPR-edited cells that survive are able to do so because of a dysfunctional p53.

The problem is that p53 dysfunction is also linked to cancer (including close to half of ovarian and colorectal cancers and a sizable portion of lung, pancreatic, stomach, breast and liver cancers as well).18

In one recent study, researchers were able to boost average insertion or deletion efficiency to greater than 80 percent, but that was because of a dysfunctional p53 gene,19 which would mean the cells could be predisposed to cancer. The fact remains that while these new technologies are fascinating with enormous potential to change the world, they're highly experimental and the stakes are high.

In 2018, He Jiankui, a Chinese scientist, claimed to have created the world's first gene-edited babies. Although the claims haven't been vetted, Jiankui says he modified the DNA of human embryos during in vitro fertilization by disabling a gene called CCR5, which could potentially make the babies resistant to infection with HIV.20

Americans Don't Want Frankenfish — Why Would They Want 'Frankenmeat'?

In the U.S., negative public opinion has been instrumental in keeping GE fish off store shelves. In 2013, a New York Times poll revealed that 75 percent of respondents would not eat GE fish and 93 percent said such foods should be labeled as such.21

The argument for gene-edited foods has been that they’re somehow more natural than GE foods, as they don’t have foreign genes inserted, only tweaks to already existing DNA. But is a meat from a mutant pig with extra muscle and vertebrae really the same as meat from a wild pig?

The U.S. Food and Drug Administration (FDA) proposed to classify animals with edited or engineered DNA as drugs, prompting backlash from the biotech industry,22 but the fact remains that we're dealing with a whole new world when it comes to food from gene-edited animals — and consumers deserve to know what they're eating.

Only then can you make an informed decision about whether or not to consume gene-edited or GE foods. Without a label, however, if such foods come to the market they'll blend right into the food chain with unknown consequences, just as has been done with GMOs in the past.

Further, since the genetic alterations are permanent and capable of being passed on to new generations, the technology has lasting ramifications for the environment and the natural world should the altered traits enter surrounding ecosystems. While such advancements in technology will undoubtedly be explored, it should be done with an abundance of caution and full disclosure to consumers.

from http://articles.mercola.com/sites/articles/archive/2019/03/12/genetic-editing-of-animals-has-side-effects.aspx

source http://niapurenaturecom.weebly.com/blog/genetic-editing-of-animals-has-horrible-side-effects

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paullassiterca · 6 years ago

Text

Genetic Editing of Animals Has Horrible Side Effects

Would you eat a burger made from a cow with lab-altered DNA? How about a potato or a piece of salmon that was similarly tweaked? Gene-editing technologies are here, and they’re already being used to alter the food supply.

The next step that biotech companies are racing to bring to the not-so-proverbial table is gene-edited farm animals. Unlike GE foods, which may have genes from other species inserted, gene editing involves altering an organism’s DNA. Like GE foods, however, gene-edited foods come with unknown risks to the animals and the people who eat them.

Gene Editing Led to Enlarged Tongues, Extra Vertebrae and Other Side Effects

Among pigs that were altered by deleting the myostatin (MSTN) gene, which limits muscle growth, the larger muscles came along with an extra vertebra in 20 percent of the gene-edited animals.

"Humans have a very long history of messing around in nature with all kinds of unintended consequences … It’s really hubris of us to assume that we know what we’re doing and that we can predict what kinds of bad things can happen.”

Gene Editing Is Being Used to Alter Physical Traits, Puberty and Diseases in Animals

Other biotech companies have taken to targeting genes intended to ease animal suffering, which they believe may soften regulators and consumers who are wary of the technology. “It’s a better story to tell,” Tammy Lee, CEO of Recombinetics, told the New York Post.8

The company has snipped out the genes responsible for growing horns in dairy cows, for instance, which means they wouldn’t be subjected to the inhumane ways the horns are currently removed (with no pain relief).

Currently, cows born with the hornless trait are being raised at the University of California, Davis, with plans to eventually test their milk for any oddities. The company is also working on editing genes so pigs don’t go through puberty. This would make castrating pigs — an inhumane procedure currently done (also without painkillers) to prevent meat from gaining an unpleasant odor — unnecessary.9

Recombinetics and other biotech companies don’t want gene-edited foods to come with any warnings or additional regulations, which could hamper the technology’s progress and acceptance by farmers. Once this occurs, though, it’s likely that gene-editing will be used less for humanity’s sake and more to create larger profits, such as via gene-editing to increase litter size.10

What Are the Consequences of Eating Gene-Edited Foods?

In fact, in March 2018, the USDA released a statement noting that it would not regulate CRISPR-edited crops, noting, “With this approach, USDA seeks to allow innovation when there is no risk present.”12

Gene editing, with its loose regulation, accessibility and quick results, has been called the next “food revolution,”13 at least for plant foods, but it’s unclear whether the same will hold true for animals. In the U.S., it’s been proposed that gene-edited foods do not need to be labeled, either, but the European Union ruled that they should be regulated the same as genetically modified organisms (GMOs).

Jaydee Hanson, an analyst at advocacy group the Center for Food Safety, told National Geographic that this may be closer to reality. “This is the new kind of genetic engineering, whether you call it transgenic [GMO] or not. It should be adequately regulated. We’re not saying it should be stopped — we should know what has been done.”14

“Many of the genome editing-induced off-target mutations, as well as those induced by the tissue culture, will no doubt be benign in terms of effects on gene function. However, many will not be benign and their effects can carry through to the final marketed product, whether it be plant or animal …

Gene Editing May Not Be as Precise as It Seems

Researchers at the U.K.’s Wellcome Sanger Institute systematically studied mutations from CRISPR-Cas9 in mouse and human cells, focusing on the gene-editing target site. Large genetic rearrangements were observed, including DNA deletions and insertions, that were spotted near the target site.

They were far enough away, however, that standard tests looking for CRISPR-related DNA damage would miss them. The DNA deletions could end up activating genes that should stay “off,” such as cancer-causing genes, as well as silencing those that should be “on.”16

In 2018, He Jiankui, a Chinese scientist, claimed to have created the world’s first gene-edited babies. Although the claims haven’t been vetted, Jiankui says he modified the DNA of human embryos during in vitro fertilization by disabling a gene called CCR5, which could potentially make the babies resistant to infection with HIV.20

Americans Don’t Want Frankenfish — Why Would They Want ‘Frankenmeat’?

The U.S. Food and Drug Administration (FDA) proposed to classify animals with edited or engineered DNA as drugs, prompting backlash from the biotech industry,22 but the fact remains that we’re dealing with a whole new world when it comes to food from gene-edited animals — and consumers deserve to know what they’re eating.

Only then can you make an informed decision about whether or not to consume gene-edited or GE foods. Without a label, however, if such foods come to the market they’ll blend right into the food chain with unknown consequences, just as has been done with GMOs in the past.

from Articles http://articles.mercola.com/sites/articles/archive/2019/03/12/genetic-editing-of-animals-has-side-effects.aspx source https://niapurenaturecom.tumblr.com/post/183396986291

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jakehglover · 6 years ago

Text

Scientists Warn: Insects With Capacity to Perform Genetic Engineering in the Environment Could Be Easily Weaponized

youtube

Genetic engineering (GE) is being used in myriad ways these days, despite the fact we know very little about the long-term ramifications of such meddling in the natural order.

For example, the Defense Advanced Research Projects Agency (DARPA), an arm of the U.S. Department of Defense, is now planning to use insects to deliver GE viruses to crops, with the aim of altering the plant’s genetic traits in the field.

The $27 million DARPA project, called “Insect Allies,” is basically trying to take advantage of insects’ natural ability to spread crop diseases, but instead of carrying disease-causing genes, they would carry plant-protective traits. As explained by The Washington Post:1

“Recent advances in gene editing, including the relatively cheap and simple system known as CRISPR (for clustered regularly interspaced palindromic repeats), could potentially allow researchers to customize viruses to achieve a specific goal in the infected plant.

The engineered virus could switch on or off certain genes that, for example, control a plant’s growth rate, which could be useful during an unexpected, severe drought.”

Insect Allies Project Raises Concerns About Bioterror Use

However, scientists and legal scholars question the rationale for the use of insects to disperse infectious GE viruses engineered to edit the chromosomes in plants, warning that the technology could very easily be weaponized.2,3,4,5

The opinion paper6 “Agricultural Research, or a New Bioweapon System?” published October 4, 2018, in the journal Science questions DARPA’s Insect Allies project, saying it could be perceived as a threat by the international community, and that if plant modification were really the ultimate goal, a far simpler agricultural delivery system could be used.

Jason Delborne, associate professor at North Carolina State University, has expertise in genetic engineering and its consequences. He told Gizmodo:7

“The social, ethical, political and ecological implications of producing HEGAAs [horizontal environmental genetic alteration agents] are significant and worthy of the same level of attention as exploring the science underpinning the potential technology.

The authors argue persuasively that specifying insects as the preferred delivery mechanism for HEGAAs is poorly justified by visions of agricultural applications.

The infrastructure and expertise required for spraying agricultural fields — at least in the U.S. context — is well established, and this delivery mechanism would offer greater control over the potential spread of a HEGAA.”

The team has also created a website8 to accompany the paper, the stated aim of which is “to contribute toward fostering an informed and public debate about this type of technology.” On this site you can also find a link to download the 38-page DARPA work plan. DARPA, meanwhile, insists the project’s goal is strictly to protect the U.S. food supply. A DARPA spokesperson told The Independent:9

“[S]prayed treatments are impractical for introducing protective traits on a large scale and potentially infeasible if the spraying technology cannot access the necessary plant tissues with specificity, which is a known problem.

If Insect Allies succeeds, it will offer a highly specific, efficient, safe and readily deployed means of introducing transient protective traits into only the plants intended, with minimal infrastructure required.”

Scientists from the U.S. Department of Agriculture are also participating in the research, which is currently restricted to contained laboratories. Still, many are unconvinced by DARPA’s claims of peaceful aims.

The release of such insects could “play into longstanding fears among countries that enemies might try to harm their crops,” says Dr. David Relman, a former White House biodefense adviser and professor of medicine and microbiology at Stanford. According to The Associated Press (AP):10

“Guy Reeves, a coauthor of the Science paper and a biologist at the Max Planck Institute for Evolutionary Biology in Germany, says the technology is more feasible as a weapon — to kill plants — than as an agricultural tool. As a result, he said DARPA could be sending an alarming message regardless of its intentions.”

Unforeseen Ramifications Abound

Others are concerned about environmental ramifications, regardless of whether the genetic traits being delivered to the plants are perceived as beneficial or harmful. According to DARPA, none of the insects would be able to survive for more than two weeks, but what if such guarantees fail? What if nature finds a way? If so, the insects’ spread could be near-unlimited.

Gregory Kaebnick, an ethicist at the Hastings Center bioethics research institute in Garrison, New York, told the AP he’s concerned the project may end up causing unforeseen environmental destruction, as insects will be virtually impossible to eradicate once released. If it turns out the genetic modification traits they carry are harmful, there will be no going back.

Yet others, such as Fred Gould, an entomologist at North Carolina State University who chaired a National Academy of Sciences panel on genetically modified food, believe the project’s stated goal of altering genetic traits of plants via insects is near-impossible in the first place.

However, while the research is still in its initial phase, they already have proof of concept. In one test, an aphid infected a mature corn plant with a GE virus carrying a gene for fluorescence, creating a fluorescent corn plant.11

Open Scientific Debate Is Needed

Reeves questions why there’s been virtually no open scientific debate about the technology. According to Reeves, who is an expert on GE insects, the Insect Allies project is “largely unknown even in expert circles,” which in and of itself raises a red flag about its true intent.

He told The Independent, “It is very much easier to kill or sterilize a plant using gene editing than it is to make it herbicide- or insect-resistant.”12 Felix Beck, a lawyer at the University of Freiburg, added:13

“The quite obvious question of whether the viruses selected for development should or should not be capable of plant-to-plant transmission — and plant-to-insect-to-plant transmission — was not addressed in the DARPA work plan at all.”

How Horizontal Environmental Genetic Alteration Agents Work

As explained in the featured paper, the technology DARPA is using is known as horizontal environmental genetic alteration agents or HEGAAs. Essentially, HEGAAs are GE viruses capable of editing the chromosomes of a target species, be it a plant of an animal. The specificity of HEGAAs are dependent on:

The range of species the GE virus can infect

The presence of a specific DNA sequence in the chromosome that can then become infected

The image below illustrates how an insect-dispersed viral HEGAA would disrupt a specific plant gene. As noted on the team’s website:

“Interest in genetically modified viruses, including HEGAAs, largely stems from their rapid speed of action, as infections can sweep quickly through target populations. This same property is also a serious safety concern, in that it makes it hard to predict where viruses geographically disperse to or what species they eventually infect.

Probably due to the complex regulatory, biological, economic and societal implications that need to be considered little progress has been made on how genetically modified viruses should be regulated when the intention is to disperse them in the environment. It is in this context that DARPA presented its Insect Allies work program in November 2016.”

Image credit: Derek Caetano-Anollés

The team also notes the use of HEGAAs are ultimately not likely to be limited to agriculture, which is why it’s so important to have an open discussion about the technology, its potential uses, misuses and ramifications — including unintended ones.

In 2018, three scientific publications discussed the development of “transmissible vaccines,” i.e., vaccines that would be transmissible between humans and therefore would no longer require individual vaccinations. Such products would also remove any possibility of informed consent, which creates a really huge ethical dilemma. In the past decade, at least seven scientific papers have focused on transmissible vaccines.

The team also brings up the obvious point that insects will not be able to distinguish between conventional crops and certified organic crops, which do not permit genetic engineering. Just how are organic farmers to keep these insect vectors from altering their crops? They can’t, and this could effectively destroy the organic industry as we know it.

DARPA Technology May Violate Biological Weapons Convention

According to DARPA, the technology does not violate the United Nations (U.N.) Biological Weapons Convention. However, according to the Science paper, it could be in breach of the U.N.’s convention if the research is unjustifiable. Silja Voeneky, a specialist in international law at Freiburg University, told The Independent:14

“Because of the broad ban of the Biological Weapons Convention, any biological research of concern must be plausibly justified as serving peaceful purposes. The Insect Allies Program could be seen to violate the Biological Weapons Convention, if the motivations presented by DARPA are not plausible. This is particularly true considering this kind of technology could easily be used for biological warfare.”

The Science team also call for greater transparency from DARPA in order to discourage other countries from following suit and developing similar delivery technologies as a defensive measure.

Gene Drive Technology Needs International Governance

In related news, Simon Terry, executive director of the Sustainability Council of New Zealand, is calling for gene drive technology to be brought under international governance,15,16,17 as this kind of technology can make an entire species infertile in a relatively short amount of time, depending on the species life cycle.

Gene drive is yet another application for CRISPR. In short, it’s a genetic engineering technology that allows you to propagate a specific set of genes throughout an entire population, including its offspring, which allows you to genetically alter the future of an entire species. Gene drive has been proposed as a means to control pests, including mosquitoes and possum.

However, there’s no known way to control it. As an example, while New Zealand would like to use gene drive to eradicate possums, it would be virtually impossible to prevent the spread of the gene drive to other areas, and in Australia, the possum is a protected species.

Gene drive has also been considered as an answer for barnyard grass, a pesky weed among Australian farmers, but a prized commodity in India. Likewise, Palmer Amaranth is considered a weed in the U.S. but an important food source in Central America, Africa, India and China. As noted by Terry, “One man's pest could be another's desired plant or animal,” and creating national regulations for a technology that can wipe out an entire species globally simply isn’t enough.

Should We Use Technology That Can Eradicate Entire Species?

In a 2016 report,18 the Institute of Science in Society (ISIS) discussed the creation of transgenic mosquitoes, carrying genes against a malarial pathogen. Using CRISPR/Cas9, a gene drive was created that makes virtually all progeny of the male transgenic mosquitoes’ carriers of this antimalaria gene. However, the transgene was found to be unstable in female mosquitoes, and key safety issues were also raised, including:

To what extent might crossbreeding or horizontal gene transfer allow a drive to move beyond target populations?

For how long might horizontal gene transfer allow a drive to move beyond target populations?

Is it possible for a gene drive to evolve to regain drive capabilities in a nontarget population?

According to ISIS, answering these questions is “crucial in the light of the instability of the gene drive in transgenic female mosquitoes.” As noted in the report:

“When these females bite animals including humans, there is indeed the possibility of horizontal gene transfer of parts, or the entire gene-drive construct, with potentially serious effects on animal and human health.

Cas9 nuclease could insert randomly or otherwise into the host genome, causing insertion mutagenesis that could trigger cancer or activate dominant viruses ...

Finally, the ecological risks of gene drives are enormous … As the gene drive can in principle lead to the extinction of a species, this could involve the species in its native habitat as well as where it is considered invasive. As distinct from conventional biological control, which can be applied locally, there is no way to control gene flow …

[B]ecause the CRISPR/Cas gene drive remains fully functional in the mutated strain after it is created, the chance of off-target mutations also remain and the likelihood increases with every generation.

‘If there is any risk of gene flow between the target species and other species, then there is also a risk that the modified sequence could be transferred and the adverse trait manifested in nontarget organisms.’ (This commentary has not even begun to consider horizontal gene flow, which would multiply the risks manyfold.)”

DARPA Brushes Off Concerns

James Stack, a plant pathologist at Kansas State University and a member on the advisory panel of DARPA’s Insect Allies project, believes the concerns raised in the Science paper are unfounded. He told The Washington Post:19

“I don’t understand the level of concern raised in this paper, and to jump ahead and accuse DARPA of using this as a screen to develop biological weapons is outrageous.

There’s risk inherent in life and you just have to manage it well. And I think as we move into a more crowded planet it’s going to put increasing demands on our food systems, our water systems. We’re going to need all the tools in the tool box that we possibly have.”

Unfortunately, recent history demonstrates we’ve not been very capable of managing these kinds of man-made risks very well at all. Just look at Roundup-resistant GMO food, for example, or electromagnetic field radiation from cellphones and wireless technologies, both of which have been shown to cause significant health and environmental problems since their inception.

There’s virtually no evidence to suggest mankind is very good at predicting the potential outcomes of our technological advancements, so unleashing gene-altering technologies that cannot be recalled or reversed seems foolish in the extreme. As mentioned, the Insect Allies project may be particularly detrimental for organic and biodynamic farming, as it would be completely impossible to prevent these gene-altering insect vectors from infecting organic crops.

from HealthyLife via Jake Glover on Inoreader http://articles.mercola.com/sites/articles/archive/2018/10/23/darpa-insect-allies-or-biological-weapon.aspx

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hcsmca · 7 years ago

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Announcing TEDMED’s 2018 Research Scholars

Preparing the TEDMED Stage Program is a year-long process, which begins the moment the first Speaker nominations come in. Each submission requires thorough research and careful consideration for how it might fit into the larger program. For help identifying the individuals and topics that will take the stage at our annual TEDMED event, we turn to the TEDMED Community—specifically our Editorial Advisory Board Members and Research Scholars—for their insight and expertise.

As a first step in the process, we rely on our Editorial Advisory Board members to suggest timely topics and themes that should be featured on stage and to provide their feedback on which Speaker nominations most embody the important work these topics and themes represent. Having completed four Editorial Advisory Board meetings and countless discussions following each meeting, the 2018 Stage Program curation process is well underway. While there is still work to do, we’re excited about how the program is shaping up.

Now comes the point in the process where we begin vetting the science and potential impact of each nomination. This is where TEDMED’s Research Scholars play a crucial role. The Research Scholars, a carefully selected group of passionate and objective individuals whose expertise spans the biomedical, public health, and emerging technology spectrums, help us to properly evaluate each nomination.

This year, we have selected 45 Research Scholars with specialties ranging from neuroscience to bioethics, digital health to nursing, and oncology to public health. We’re confident that the 2018 Research Scholars have the diverse backgrounds and breadth of knowledge that will allow us to take a deep dive into the complexities of this year’s Speaker nominations and to evaluate their suitability for this year’s program.

Our 2018 Research Scholars represent organizations and institutions including the Cleveland Clinic, Johns Hopkins University, the YMCA of the USA, Skoll Global Threats Fund, Icahn School of Medicine at Mount Sinai’s Loeb Center for Alzheimer’s Disease, GE Healthcare, the The University of Pittsburgh, the American Medical Association, and more.

Additionally, we’re excited to announce that we’re trying something new this year. We’ve partnered with Massive, a digital science media publication that brings together scientists and the science-curious public, and tapped into their pool of first-rate researchers to help us evaluate this year’s nominations. The TEDMED-Massive Scholars are members of TEDMED’s 2018 Research Scholars Program, and they are denoted by an asterisk in the list below. We’re excited about the TEDMED-Massive partnership, and we’re looking forward to sharing more over the coming months about how we’ll work together.

We are honored to announce this year’s TEDMED Research Scholars, and we thank them for their invaluable contributions.

Akash Chandawarkar, MD Plastic Surgery, Medical Technology Innovation

*Anastasia Gorelova, PhD Candidate Molecular Pharmacology, Cardiovascular Biology

Anna Pimenova, PhD Neuroscience, Neurodegeneration

*Aparna Shah, PhD Neuroscience, Pharmacology, Psychiatric Disorders

Beth Ann Swan, PhD, CRNP, FAAN Healthy Communities, Health Care Delivery

Beth Taylor Mack, PhD Health and Wellness Innovation

Boluwaji Ogunyemi, MD Epidemiology, Dermatology, Medical Humanities, Health Advocacy

Bryon Petersen, PhD Bioengineering, Stem Cell Biology

Camilla Engblom, PhD Cancer Immunology

Christina Schweitzer, MPhil (Cantab), BSc, MD student Medical Education

*Dan Samorodnitsky, PhD Molecular Biology

Daniel Bu Health Care Delivery, Science and Technology

Danny Jomaa, MSc Candidate Cancer Biology, Neuroscience

Diana Chen, MA, MD/MBA Candidate Global Health, Healthcare Delivery, Marketing

Dilip Thomas, PhD Tissue Engineering, Regenerative Medicine

Elisa L Priest, DrPH Healthcare Quality, Epidemiology, Population Health

Elizabeth Rochin, PhD, RN, NE-BC Maternal Health, Population Health, Patient Engagement

Emal Lesha, MD Candidate Bioengineering, Biotechnology, Health Care

Emilie Grasset, PhD Immunology

*Gabriela Serrato Marks, PhD Candidate Climate Change, Science Communication

Gyan Kapur Healthcare Technology, Genomics

*Irene Park, MS Genetics, Science Communication

Jeffrey L. Blackman, MBA Corporate Innovation, Entrepreneurship

Jennifer Olsen, DrPH Public Health, Data Utilization

*Josh Peters, PhD Candidate Quantitative Biology, Genomics, Infectious Disease

Joshua Brown, PharmD, PhD Health Economics and Outcomes Research

Kaylynn Purdy, H BHSc, MD Candidate Medical Education, Health Advocacy, Neuroscience

Kelly Jamieson Thomas, PhD Cancer Prevention, Wellness Education

*Laetitia Meyrueix, PhD Candidate Nutrition, Epigenetics, Public Health

Maria Papageorgiou, MSc, MBA Market Access, HTA, Health Economics, Marketing

Meg Barron, MBA Digital Health, Healthcare Innovation

*Melanie Silvis, PhD Candidate Microbiology, Genetics, Genome Engineering, Antibiotic Discovery

Nicole Stone, PhD Cardiac Reprogramming, Epigenomics

Paul Lindberg, JD Public Health, Healthy Communities

Pierre Elias, MD Cardiology, Data Science

Pramod Pinnamaneni, MD Oncology, Healthcare Innovation, Cost and Utilization

Raja R Narayan, MD MPH General Surgery, Medical Device Innovation

Regina Wysocki, MS, RN-BC Nursing Informatics, Healthcare Information Technology

Shaahin Dadjoo, DMD Candidate Dental Medicine, Craniofacial Development, Mindfulness

Steven Randazzo Open Innovation, User-Centered Design

Tabitha Moses, MS Bioethics, Medicine, Neuroscience, Public Health

Tanmay Gokhale, MD PhD Candidate Biomedical Engineering, Computational Modeling, Cardiology, Entrepreneurship

*Yewande Pearse, PhD Neuroscience, Gene Therapy, Stem Cell Therapy

Zuber Memon Affordable Healthcare Technologies, Open Innovation

*Massive-TEDMED Scholar. Learn more about Massive at massivesci.com.

The post Announcing TEDMED’s 2018 Research Scholars appeared first on TEDMED Blog.

Read more from TEDMED https://blog.tedmed.com/announcing-tedmeds-2018-research-scholars/#utm_source=rss&utm_medium=rss

#TEDMED #California #HCSM #2016

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nothingman · 7 years ago

Link

Yue Shao had never seen anything quite like it.

Two years ago, Shao, a mechanical engineer with a flair for biology, was working with embryonic stem cells, the kind derived from human embryos able to form any cell type. As he experimented with ways of getting cells to form more organized three-dimensional structures by growing them in scaffolds of soft gel, he was looking for signs of primitive neural tissue.

What drew his attention was that the cells seemed to change much faster than expected—they arranged themselves rapidly over a few days into a lopsided circle.

What was it? Shao startled Googling to see if he could identify the structure. That’s when he landed on a website called The Virtual Human Embryo and found some microscope photos of ten-day old human embryos shortly after implantation, fused to the uterine wall. There was the beginning of the amniotic sac and, inside it, the embryonic disc, or future body. They matched what he was seeing.

In this microscope movie, filmed over four days, stem cells self-organize in ways that mimic a human embryo.

Courtesy of University of Michigan

Shao informed his coworkers, a mixed team of biologists and engineers, at the University of Michigan. “When I showed the image to the team, everyone said, “Wow, we need to figure out what to do,” says Shao. Had they somehow made a real human embryo from stem cells? “At that point, we started to be more cautious.”

The embryo-like structures, the team soon determined, are not complete and couldn’t become a person. They lack the cell types needed to make a placenta, a heart, or a brain. Even so, the Michigan “embryoids” are realistic enough that the lab has been destroying them using a bath of detergent or formaldehyde to make sure they don’t develop any further.

The work in Michigan is part of a larger boom in organoid research—scientists are using stem cells to create clumps of cells that increasingly resemble bits of brain, lungs, or intestine (see “10 Breakthrough Technologies: Brain Organoids”). Now some like Shao are finding it’s possible to mimic the embryo itself. This year, for example, researchers in Cambridge, U.K., built a convincing replica of a six-day-old mouse embryo by combining two types of stem cells. That group is now trying to do the same with human cells, as are a few others, including one at Rockefeller University in New York. What’s emerging, say scientists, is a new technology, which they call “synthetic embryology,” and which they believe may let them probe the fascinating opening chapters of human development in detail for the first time.

That’s been difficult to do because normal embryos don’t keep growing more than about a week in a lab. Key events after that are largely inaccessible to science: they occur in the darkness of the human uterus even before most women know they’re pregnant.

A microfluidic device used at the University of Michigan to cultivate organoids made from embryonic cells. About 10 organoids can fit inside each of the small blue channels.

What’s more, research on real human embryos is dogged by abortion politics, restricted by funding laws, and limited to supplies from IVF clinics. Now, by growing embryoids instead, scientists see a way around such limits. They are already unleashing the full suite of modern laboratory tools—gene editing, optogenetics, high-speed microscopes—in ways that let them repeat an experiment hundreds of times or, with genetic wizardry, ask a thousand questions at once.

One result already from the Michigan team: dramatic close-up video of stem cells self-organizing into structures that mimic embryos.

“It’s amazing that [stem cells] have this capability,” says Jianping Fu, the University of Michigan professor in whose engineering lab Shao was a student. He says the emergence of something with an embryo’s shape, and some of its features, was “a complete surprise; I still can’t believe it. But it shows these cells remember what they are supposed to do.”

Scientists at Michigan now have plans to manufacture embryoids by the hundreds. These could be used to screen drugs to see which cause birth defects, find others to increase the chance of pregnancy, or to create starting material for lab-generated organs. But ethical and political quarrels may not be far behind. “This is a hot new frontier in both science and bioethics. And it seems likely to remain contested for the coming years,” says Jonathan Kimmelman, a member of the bioethics unit at McGill University, in Montreal, and a leader of an international organization of stem-cell scientists.

What’s really growing in the dish? There no easy answer to that. In fact, no one is even sure what to call these new entities. In March, a team from Harvard University offered the catch-all “synthetic human entities with embryo-like features,” or SHEEFS, in a paper cautioning that “many new varieties” are on the horizon, including realistic mini-brains.

Shao, who is continuing his training at MIT, dug into the ethics question and came to his own conclusions. “Very early on in our research we started to pay attention to why are we doing this? Is it really necessary? We decided yes, we are trying to grow a structure similar to part of the human early embryo that is hard otherwise to study,” says Shao. “But we are not going to generate a complete human embryo. I can’t just consider my feelings. I have to think about society.”

Other scientists, however, are determined to see just how far the science leads, up to and including forging the first complete human embryo from stem cells. That’s the case of Ali Brivanlou, an embryologist who leads a lab at Rockefeller University, in New York City. “My goal is to maximize the modeling, in vitro, of human development,” Brivanlou wrote in an e-mail. “Therefore, we would like to be as accurate as possible and as complete as possible.”

Taking shape

Embryonic stem cells were first isolated from spare, days-old IVF embryos in 1998 by scientists in Wisconsin. Early on, in its first few days, an embryo is little more than a mass of these identical, blank-slate, cells. Their specialty: making any other type of cell in the body. With an eye toward eventual medical treatments, companies have used them to produce neurons and beta cells that respond to insulin. Left alone in a dish, they’ll spontaneously turn into heart muscle and start beating.

Scientists have started seeking ways to coax stem cells to form more complicated, organized tissues, called organoids. These mini-organs aren’t the real thing. Instead, they’re far smaller—the size of sand grains—and often less sophisticated. But they can still have basic aspects of, say, the branching airways and wavy cilia of a lung. Last year, researchers used brain organoids to show how the Zika virus can infect brain cells.

By 2014, such efforts started yielding evidence that stem cells might, if given the right cues, directly reenact early events in an embryo. Brivanlou’s lab had the idea of corralling stem cells within tiny dots on a micro-patterned surface. Containing the cells helped lead to a surprising effect. They developed an organized “primitive streak”—a feature of a two-week-old human embryo when cells lay down the first hint of a body plan, deciding which side is left which is right.

Those embryoids were not natural. They were thin, grown as a flat sheet, and their streaks were circles, not lines as in a true embryo. “But it worked better than we thought,” says Aryeh Warmflash, a Rice University professor who ran the experiment while working at Rockefeller. “What we have increasingly realized is that the cells are programmed to make an embryo. That is what they want to do. If cells are in the right shape, at the right density, and you give them the right signal, the cells just take over from there, they talk to each other.”

At Michigan, Fu says his lab, working with Michigan biologist Deborah Gumicio, hit on its own method for making embryoids almost by accident while studying whether mechanical signals, like growing cells in a gel that is soft or sticky, could enhance their ability to form certain tissues.

One experiment involved encouraging gut cells to form a lumen, or hollow cyst. As a control experiment, they also cultivated embryonic stem cells in the same way. That is when “serendipity hit,” says Fu. The stem cells polarized into spheres that bore similarity to the start of an amniotic cavity. “[After] that is when we saw all the fascinating self-organizing features,” says Fu.

Ethical questions

Further tests demonstrated that the embryoids represented only a part of the embryo. While they had the beginnings of an amniotic sac, they lacked an entire lineage of cells, called trophoblast, whose role is to make the placenta. And inside the clump of cells that constitutes an embryo proper, the researchers detected only one of three key types needed to make a complete body.

When the team published its findings in early August, they went mostly unnoticed. That is perhaps because the scientists carefully picked their words, straining to avoid comparisons to embryos. Shao even took to using the term “asymmetric cyst” to describe the entities that had so surprised the team. “We have to be careful using the term synthetic human embryo, because some people are not happy about it,” says Fu.

An “embryoid” created from stem cells shares key features with a real human embryo, like an amniotic sac, but lacks other elements.

Courtesy of Yue Shao, Massachusetts Institute of Technology.

Currently, scientists in the U.S. and U.K. working with natural human embryos observe a limit on their work called the “14-day rule.” No human embryo is studied beyond two weeks, or past when the primitive streak forms, whichever comes first. Before then, no one thinks they have any kind of sentience and are “incapable of feeling pain” according to the 1984 Warnock Report that enshrined the rule.

For decades, that rule has offered a convenient and clear line in the sand. And the same limits are being applied to embryoids, at least for now. Following guidelines promulgated last year by Kimmelman’s international stem-cell society, Fu’s team destroys the cells just five days after they’re made. This prevents the structures from developing what bioethicists term “features of concern”—such as a primitive nervous system.

But scientists are prepared to argue that their structures aren’t real embryos, and that they should be able to stretch the limit. Some experts are calling for an end to the rule altogether, saying it is outdated. John Aach, a scientist at Harvard Medical School, thinks entirely new ethical measuring sticks will be needed to help guide tests of organoids. For instance, could a mini-brain grown in the lab somehow feel suffering? And can our definition of an embryo withstand evidence that labs can make new sorts never before seen? “All great scientific advances have a way of exposing the imprecision of common concepts and forcing people to rethink them,” says Aach.

Even before his paper came out, Shao was buttonholing ethics experts, including Insoo Hyun, a professor at Case Western University, at a conference this year in Boston. Hyun felt the young researcher was on safe ground because his structure didn’t contain every part of an embryo. “I think that they should design experiments to focus on specific questions, and not model everything,” says Hyun. “My proposal is, just don’t make the whole thing. One team can make the engine, another the wheels. The less ambiguous morally the thing is that you are making, the more likely you can do your research unimpeded.”

There’s yet another reason to be cautious. The U.S. currently bars federal funding for any study of embryos, no matter how they are made, under a law called the Dickey-Wicker Amendment.

While today’s embryoids don’t appear to be covered by the legal restriction, they might be if scientists make them realistic enough. In response to written questions, the science policy office of the National Institutes of Health, the $33-billion-a-year funding agency, says it has an internal process it uses to analyze grants and to determine if “proposed research would create an organism that meets the statutory definition of a human embryo.”

The Michigan scientists, whose project used funds from two NIH grants, say agency officials haven’t raised any objections so far. For now, the embryoids live and die in boxes made of lucite and metal and are fed with culture medium. “Because of the really heavy engineering component to these entities, I think you will be able to argue these are not organisms,” says Hyun. That’s a point that Shao has sought to emphasize, too. When Shao presented the group’s work this year, he added to his slides an ethics statement outlined in a bright yellow box, saying the embryoids “do not have human organismal form or potential.”

But such definitions could be a moving target. The whole point of the structures is the surprising, self-directed, even organismal way they develop. Robert Cork is the head of the Virtual Embryo Project, which maintains the images the Michigan team used to identify their structures. When I asked him about Shao’s paper, Cork told me that the embryoids could go on to make some of the parts they’re currently missing, if the experiments were allowed to progress. “This would suggest that if they can keep the cysts viable for longer they might go ahead and start to develop into something more ‘embryo-like,’” says Cork.

High-throughput

Jianping Fu is a professor of mechanical engineering at the University of Michigan.

Courtesy of University of Michigan.

Fu says the next step in his Ann Arbor laboratory is to perfect procedures for making embryoids with specific characteristics, and in larger numbers. Initially, of every 100 “cysts” the Michigan scientists grew, only five ended up with the asymmetric shape reminiscent of the amniotic sac. But the they have already learned how to make that shape emerge every time. The production of embryoids will become “programmable and scalable,” Fu predicts.

Drugs could be tested on the embryoids, for instance to flag any that have toxic effects and cause birth defects. Fu’s hope is that synthetic embryology might eventually help engineers grow complete human organs. “I am not talking about a human body without a brain. But what is a true possibility is you could develop a mini-gut or a mini-liver, since the embryo develops them, too. And if you have the primitive organs, they could grow into a functional one,” Fu predicts. The lab has started growing embryoids on a chip about the size of a credit card. Etched into it are six microchannels, each accommodating 10 of the entities, which are suspended in hydrogels and fed nutrients held in miniature buckets. Fu calls it “high-throughput manufacturing.”

This way, he says, “everything can be triggered and under control.”

via New on MIT Technology Review

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thrivous · 7 years ago

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Continuing our series of interviews with Thrivous Science Advisors, we present this interview with Dr. Jordan Roberts, a physician with a medical degree from the University of Arizona, who currently works in family medicine at St. Mark's Hospital in Salt Lake City.

Could you briefly introduce yourself and your personal and scientific background?

I am a resident family medicine physician at St. Mark’s Hospital in Salt Lake City. I received a Bachelor’s of Science in Life Sciences from Arizona State University in 2011, and a Doctor of Medicine from the University of Arizona College of Medicine - Phoenix in 2015. I have done scientific research on Calcium homeostasis in S. cerevisiae as an undergraduate and a clinical thesis on vitamin D levels in inmates of the Maricopa County Jail as a medical student. My research aims as a physician have centered on improving access and overcoming barriers to evidence-based preventive health services, with a particular interest in adolescents. I am married and have two young children.

How did you become interested in nootropics and a Thrivous scientific advisor?

Lincoln Cannon approached me directly asking if I would be willing to consider joining his scientific advisory board. At first, I was skeptical and felt myself a poor fit for the position (I had recently published a piece, wherein I expressed my doubts about the effectiveness of mixed supplementation for significant biological and cognitive enhancement); however, after seeing multiple good quality studies, and the method in which Lincoln would compile this data to guide his therapeutic inclusion criteria for different active ingredients, I decided that I felt comfortable adding my voice to that of other scientists on the board to provide critical analysis and feedback on new ideas and products from Thrivous.

I understand that you have recommended Clarity to some of your patients. Could you share some feedback from your patients?

I have recommended Clarity (and provided samples) to several of my patients who suffer from Adult Attention Deficit Disorder as an adjunct to traditional stimulant therapy. Their initial reactions have been mild, but positive and they have so far reported no adverse reactions.

To whom would you recommend Thrivous' nootropics?

I would recommend them to those who have a subclinical deficit in their ability to concentrate, or who express difficulty with memory that does not significantly affect their instrumental activities of daily living. I would also recommend nootropics to those who have a diagnosis of ADD or memory loss but who are stable on medical therapy and/or cognitive-behavioral therapy, and have regular follow up with a medical provider. Enhancement, for practical intents and purposes, currently lies beyond the scope of traditional medicine. I do not routinely recommend therapy to asymptomatic and “normally functioning” patients, but I do not discourage it, either, as long as they understand the potential risks and benefits.

What is the regulatory status of nootropics, and what's the FDA's position? Where is the line between unregulated and regulated?

Natural nootropics, such as those found in Clarity, fall into the category of food supplements in the eyes of the FDA, and manufacturers are not required to provide proof of safety or efficacy (via clinical trials) before they are made available to the general public for sale and consumption. There is minimal effort in the biomedical/pharmaceutical community to derive the “active ingredients” of the various, known natural nootropics to create patentable synthetic compounds to test and bring to market via the traditional drug development process, which is lengthy and expensive (costing up to one billion dollars per drug).

Natural nootropics do not require a doctor’s prescription or routine monitoring. Traditional regulatory agencies do not require strict pre-market manufacturing standards and testing, and so it is often difficult or impossible to know with certainty about the quality and quantity of the product one may purchase online or at a health food store. The industry is largely “self-regulated” at this time, and with any industry left to its own devices there are good and bad actors.

I have good reason to believe that Thrivous, under the direction of Lincoln Cannon, is an honest and trustworthy supplier of high-quality and rigorously controlled natural nootropics. I do not claim any empirical knowledge about their effectiveness on their stated uses, other than the few anecdotal reports I have received from my patients and friends who use the product and the objective data in the medical literature.

Lincoln has compiled an impressive database of primary research studies on each of the components in Clarity and other labels from Thrivous, and has developed a weighted system to measure the effect of each component. A meta-analysis (a powerful method of combining data from primary studies to measure average effect size) published in the British Journal of Clinical Pharmacology in 2012, demonstrated a large and statistically significant, positive effect on delayed word recall for Bacopa monnieri (one of the primary ingredients in Clarity), an effect which is at least non-inferior to modafinil -- the only FDA approved nootropic and a scheduled/controlled substance registered with the DEA (Br J Clin Pharmacol. 2013 Mar;75(3):728-37. doi: 10.1111/bcp.12002).

What are the most exciting advances in today's biomedical research?

There are so very many! The rate at which new drugs are coming to market and the re-purposing of old, “orphan” drugs for new applications is staggering. It is important to remember, though, that the modern pharmacopeia only targets a small fraction (less than 1%) of the theorized sum-total of biochemical pathways in the human organism. Without a revolution in the way drugs are discovered and produced, this is not likely to increase exponentially as will be the case with many other technological applications. There are, however, other avenues of intervention, such as gene therapy, which could represent a new chapter in the grand story of medicine, a story which has lately been largely confined to the modern paradigm born during the age of vaccines and antibiotics in the prevention and treatment of infectious diseases.

Is CRISPR-Cas9 hype or hope?

CRISPR-Cas9 is the most precise, effective and potentially revolutionary suite of gene-editing technologies the world has yet seen. Had it not been for the Nobel Prize’s “rule of three,” the 5 co-discoverers would have certainly been the recipients of the prize for chemistry. There is currently a tenuous, self-imposed moratorium on human germ-line editing by the wider scientific community, with several notable exceptions (in the last month a lab in Oregon followed the example of several labs in China who have forged ahead with gene-editing in human embryonic stem cells), but several large studies for targeted tissue interventions in various disease states (e.g. HIV) are underway in the United States and Europe using this technology, and countless others have been proposed. Time will tell (and soon) whether these technologies offer safe and effective means of therapy to those who suffer from genetic diseases or disease states where genetic interactions play a significant role (which is most disease states).

What's your position on the science and bioethics of human enhancement, and the prospects to re-engineer humans?

Speaking personally, as a scientist, a humanist, a student of history and a man of Jewish inheritance, I am cautiously optimistic about the potential of ethical, informed, voluntary and medically supervised human enhancement. I believe each of these elements (and probably others) are necessary to avoid the pitfalls of negative eugenics, genocide and widespread discrimination and prejudice which have plagued our past and been presciently foretold by modern philosophers, clerics and authors in the darkest visions of our future.

I believe there is a positive feedback loop in place which, barring existential catastrophe, will eventually lead human beings to learn to read and (re-)write their “source code,” and that of other life. This will lead to a great diversification of life forms, but also great threats to the homeostasis that slow evolutionary forces have shaped over millions-billions of years, and so these experiments should be approached with the greatest humility and respect for the wisdom of the natural world. I feel that the future will need new bodies of governance, methods of massive informed consent and protections for life that does not have a voice in order to ethically enact such changes to this biosphere, and other new biospheres.

Do you consider yourself a transhumanist? By the way, what does that mean?

A transhumanist is a person who embraces the ethical and voluntary application of chemical, mechanical, digital and other technological enhancements to reduce human suffering, improve person-centered and culturally valued abilities, the creation and preservation of desired cognitive states, the extension of biological human lifespan and the adoption of brain-computer interfaces with the explicit goal of conscious immortality. The implicit end of such a transitional form is the post-human, and transhumanists hope to imbue the post-human progeny of humankind with our best attributes and the greatest chance of long-term survival and flourishing. I do consider myself a transhumanist.

Learn more about Dr. Jordan Roberts →

Originally published at thrivous.com on August 30, 2017 at 10:58AM.

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harjgtheonedba · 8 years ago

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The creation of a hybrid species in the near future is real. Rise of H: HARJGTHEONE WORLD ORDER IS NEEDED TO ADDRESS THESE ISSUES:

Ethical Guidelines on Lab-Grown Embryos Beg for Revamping, Scientists Say It may be time to update the currently observed 14-day rule as a benchmark

For nearly 40 years scientists have observed their self-imposed ban on doing research on human embryos in the lab beyond the first two weeks after fertilization. Their initial reasoning was somewhat arbitrary: 14 days is when a band of cells known as a primitive streak, which will ultimately give rise to adult tissues, forms in an embryo. It is also roughly the last time a human embryo can divide and create more than one person, and a few days before the nervous system begins to develop. But the so-called 14-day rule has held up all this time partly because scientists could not get an embryo to grow that long outside its mother’s body.

Researchers in the U.K. and U.S. recently succeeded for the first time in growing embryos in the lab for nearly two weeks before terminating them, showing that the so-called 14-day rule is no longer a scientific limitation—although it remains a cultural one. Now, a group of Harvard University scientists has published a paper arguing that it is time to reconsider the 14-day rule because of advances in synthetic biology.

The U.S. has no law against growing embryos beyond two weeks—as long as the research is not funded with federal dollars. But most scientific journals will not publish studies that violate the 14-day rule, and the International Society for Stem Cell Research requires its members to agree to the rule in order to qualify for membership.

The guideline, first proposed in the months after Louise Brown became the first baby to be born via in vitro fertilization in 1978, assumes that development always follows a linear path: a fertilized egg forms an embryo, which grows and develops each day. But thanks to advances in synthetic biology, the scientists warn in the new paper that researchers will someday be able to skip such developmental steps—creating humanlike collections of organs that do not have to go through these early embryonic stages of development. “We can get so distracted by the apparent issues with embryos that we might miss issues more likely to have a huge impact on society and commercial and governmental policies,” says George Church, the Harvard Medical School synthetic biologist and geneticist who is the senior author of the article, published Tuesday in eLife.

Church says he does not think any team is working to make an advanced-stage human embryo in a lab. But his own work suggests the 14-day rule does not provide adequate guidance for synthetic biologists, who take an engineering approach to understanding and manipulating life. Six years ago, for instance, researchers in his lab tried to grow human stem cells on an embryonic scaffold to see if the cells would develop into various organs. That particular attempt didn’t work, he says, but someday research on such “synthetic human entities with embryolike features” or SHEEFs, might succeed.

In addition, scientists in his lab and others are making primitive “organoids”—mini organs made to work like the kidney, lung, heart or even the brain—that could be used to test drugs or someday even replace failing body parts. It is not unreasonable, Church says, to envision a time when a scientist could create organoids from a number of different organs to see how a drug affects multiple organ systems or when someone could make a cluster of nerve cells in a dish capable of sensing what we call pain.

Now is the time to begin a public discussion on experiments such as these, Church argues, before it is scientifically viable and poses an ethical challenge to the 14-day rule.

Not surprisingly, these ideas have triggered some opposition among bioethicists. The Rev. Tadeusz Pacholczyk, a neuroscientist and director of education at the National Catholic Bioethics Center in Philadelphia, wrote via e-mail that any research on embryos or something like them is unethical, regardless of the 14-day rule. “In cases of doubt, where one has a suspicion but not certainty that one might be engendering an embryonic human, such experiments should not be continued,” he wrote.

Others, however, praised Church for starting the discussion before the science catches up with it. “I think it’s a service to write a paper like this,” says Josephine Johnston, director of research at the Hastings Center, a nonpartisan bioethics research institution. “Not every scientist wants to draw attention to why their research may cross some boundaries.”

The work of synthetic biologists poses particular ethical challenges in part because their models are getting more and more accurate, says Insoo Hyun, a bioethicist at the Case Western Reserve University School of Medicine. “Now we’re getting into experiments that call into question some of our deepest beliefs philosophically about what it means to be human and what it means to deserve moral respect.” Between synthetic biology and artificial intelligence a future might not be far off in which we have to ask whether something created in a lab is truly alive, Hyun says, conjuring up images of Mary Shelley’s Frankenstein. Having a discussion ahead of time should help prevent decision-making based on gut instinct of what seems offensive versus well-reasoned arguments, Hyun notes.

The eLife paper comes at a busy time in bioethics. Earlier this month researchers at the University of Cambridge published a mouse study showing that they could create a natural-looking embryo—starting not with eggs and sperm but with embryonic stem cells that can become any tissue in the body as well as trophoblast stem cells, which give rise to the placenta. If these results could be reproduced with human cells, it would pose some serious ethical questions.

And earlier this year the National Academy of Sciences and the National Academy of Medicine issued a report updating guidance on editing the human germ line—cells that can pass on their genetic material to future generations—which has long been another ethical line in the sand for researchers. Its expert committee concluded that it remains too risky to change an embryo’s genes for the sake of enhancing a person’s abilities. The group did, however, articulate a set of criteria by which modifying the human germ line would someday be permissible for treating or preventing disease. Although they kept the door locked against such genetic modification, their conclusions allowed scientists to metaphorically knock on that door, says committee member Jeffrey Kahn, director of the Johns Hopkins Berman Institute of Bioethics. “We didn’t even think about knocking on the door before.”

There is no international body in place to make or revise guidelines such as the 14-day rule. In the U.S. the National Academy of Sciences or a presidential commission on bioethics has traditionally made ethical recommendations about scientific research, with Congress sometimes blocking federal funding. Some other countries have standing committees, such as the U.K.’s Human Fertilization and Embryology Authority, which regulate embryonic research. Synthetic biology falls between the cracks, though, with no one having such clear authority to regulate the work, Church and his colleagues wrote in the eLife paper.

Church says he has seen more problems arise from underregulation of science rather than overregulation, citing the death of three early gene therapy patients and earlier from the drug thalidomide, which was sold to prevent morning sickness but led to terrible birth defects. Church says he does not know where new boundaries should be drawn to contain future synthetic biology research—but instead of a stop sign at the end of the research road, like the 14-day rule, his team imagines a perimeter fence to keep scientists from straying too far from an ethical path.

George Annas, director of Boston University School of Public Health’s Center for Health Law, Ethics and Human Rights, says he is glad Church and colleagues are flagging this research, which might otherwise be overlooked. He also agrees that recent advances in stem cell science, genetics and synthetic biology suggest it is time to question whether the 14-day rule has outlived its usefulness: “I think it’s a fair question,” he says.

scientificamerican.com

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