Hot Topics: Stem Cells
by Craig Klugman, Ph.D.
Move over United States, China is the new research powerhouse. In the last few months, announcements out of China talk about the first live human births from genetically edited embryos; the birth of 5 cloned, genetically edited monkeys, and most recently, announced the development of an artificial intelligencethat is more accurate than human doctors at diagnosing diseases in children.…Full Article
by Jeffrey P. Kahn, Ph.D., M.P.H. and Anna C. Mastroianni, J.D., M.P.H.
National Institutes of Health Director (NIH) Francis S. Collins and Food and Drug Administration Commissioner Scott Gottlieb recently co-authoreda New England Journal of Medicinecommentary suggesting that special oversight of gene transfer research in humans was no longer necessary.…Full Article
A couple of gene-editing news items from this week’s science literature: First, Nature reports that a group in my “back yard,” at the University of California San Diego, has tested gene editing using the CRISPR approach in mice. Recall that CRISPR is an acronym for a particular molecular mechanism, first discovered in bacteria, that is …Full Article
That’s only a slight paraphrase of a news feature article this week in Nature. The clearly-written article is devoid of scientific jargon, with helpful illustrations, open-access online, and readily accessible to the non-specialist. Check it out. Key points include: Scientists who do not find it ethically unacceptable to create and destroy human embryos solely for …Full Article
Hat-tip to Dr. Joe Kelley for bring this to my attention… As readers of this blog will recall, there is keen interest in exploiting recent discoveries in genetic engineering to “edit” disease-causing gene mutations and develop treatments for various diseases. Initially, such treatments would likely use a patient’s own cells—removed from the body, edited to change the cells’ genes in a potentially therapeutic way, then... // Read More »Full Article
One might think with the amazing advance of technology and easy access to nearly infinite data via the Internet that we, as a society, would see a reduction in false claims of benefit for novel medical procedures and untested medications. Sadly, it seems to be just the opposite. I seem to be spending gradually more time with my patients reviewing the results of their internet... // Read More »Full Article
In May of this year, my brief essays (literally, “attempts”) on synthetic human entities with embryo-like features, or SHEEFs for short, sought to ask what sort of human cellular constructs might or might not enjoy full human moral status; to wit, the right to life. Some experimenters with SHEEFs have suggested that, since they may bypass the early (14 days of life) markers that normal,... // Read More »Full Article
When any business over-promises and under-delivers, it is well on its way to failure. Does this principle also hold true in the world of stem-cells? In the last few months the promise of stem cell treatment has met the reality of government oversight. Does the government have the responsibility to rein in the larger-than-life claims of stem cell treatment clinics? In a letter dated August 24, 2017... // Read More »Full Article
Nature has recently carried two new reports of human gene editing. In one, embryos donated from an IVF clinic had a gene critical to very early development altered, to study what happens when you do that, and try to understand early human development more than we now do. In the other, scientists studied editing of an abnormal recessive gene, specifically the one causing a type... // Read More »Full Article
Obfuscation and science would seem to be polar opposites. The scientific method hinges upon correctly identifying what one starts with, making a single known alteration in that starting point, and then accurately determining what one ends up with. Scientific knowledge results from this process. Accidental obfuscation in that three-step process necessarily limits the knowledge that could potentially be gleaned from the method. Peer review normally... // Read More »Full Article
The Argument from Potentiality in the Embryo Protection Debate: Finally “Depotentialized”?
Response to Open Peer Commentaries on ?Visual Bioethics?
Rescuing Human Embryonic Stem Cell Research: The Blastocyst Transfer Method
Japan has approved a stem-cell treatment for spinal-cord injuries. The event marks the first such therapy for this kind of injury to receive government approval for sale to patients.
“This is an unprecedented revolution of science and medicine, which will open a new era of healthcare,” says oncologist Masanori Fukushima, head of the Translational Research Informatics Center, a Japanese government organization in Kobe that has been giving advice and support to the project for more than a decade.
But independent researchers warn that the approval is premature. Ten specialists in stem-cell science or spinal-cord injuries, who were approached for comment by Nature and were not involved in the work or its commercialization, say that evidence that the treatment works is insufficient. Many of them say that the approval for the therapy, which is injected intravenously, was based on a small, poorly designed clinical trial.Full Article
Most Americans say it would be OK to use gene-editing technology to create babies protected against a variety of diseases — but a new poll finds they’d draw the line at changing DNA so children are born smarter, faster or taller.
A month after startling claims of the births of the world’s first gene-edited babies in China, the poll by The Associated Press-NORC Center for Public Affairs Research finds people are torn between the medical promise of a technology powerful enough to alter human heredity and concerns over whether it will be used ethically.Full Article
Brisbane, Calif.-based Aimmune Therapeutics recently sparked optimistic headlines after releasing clinical trial results that its allergy product, AR101, would reduce the risks linked to an accidental exposure to peanuts.Full Article
Chinese scientists have raced ahead in experimenting with gene-editing on humans in the last few years, using a powerful new tool called Crispr-Cas9 to edit the DNA of dozens of cancer patients.
Information gathered by The Wall Street Journal shows one such trial has lost touch with patients whose DNA was altered, alarming some Western scientists who say subjects should be monitored for many years.Full Article
Twelve patients became seriously ill after receiving injections that supposedly contained stem cells from umbilical cord blood, according to the Food and Drug Administration, which issued a warning to the California company, Genetech, that made the blood product they were given.
(The company has no connection with Genentech, the biotechnology corporation.)
The F.D.A. said on Thursday that it had also written to 20 clinics that offer unapproved stem cell treatments, warning them that such products are generally regulated by the agency and encouraging the clinics to contact federal regulators before November 2020, when enforcement will tighten. The names of the clinics have not been released.Full Article
Ever since scientists created the powerful gene-editing technique CRISPR, they have braced for the day when it would be used to produce a genetically altered human being. Now, the moment they feared may have come. What’s likely to happen next?Full Article
The shutdown of the HIV research at the federal lab in Montana, first reported in Science, was never disclosed publicly by government officials, who have forbidden affected researchers from discussing what happened. But colleagues say they are incensed by the action, which has fanned a controversy that pits the biomedical research community against antiabortion activists and other social conservatives pressing the administration to stop the flow of federal grants and contracts for work involving fetal tissue. Such tissue comes from elective abortions.Full Article
Sick people should not be subjected to the risks of an experiment whose underlying science has been called into question.Full Article
More than a decade after a fraud scandal in stem-cell science rocked South Korea, scientists in the field are ramping up pressure on the government to relax the country’s strict regulations on human-embryo research — which many researchers label a ban.Full Article