An alarming new study finds that stem cells are being used incorrectly nationwide.
A terrifying new study finds that stem cell treatments in the United States aren’t all they’re cracked up to be.
Two researchers published a study in Cell that found 351 businesses selling stem cell interventions from 570 American-based clinics, according to the paper.
Marketing stem cell treatments directly to consumers, especially to those desperately seeking help for a terminal illness, is against federal regulations for obvious reasons, but it appears to be happening on a regular basis nationwide.
The website often attempt to deceive visitors by linking to scientific studies and patient testimonials to give an impression that an unapproved procedure has solid grounding in science.
Often, the treatment centers will claim it is a clinical trial when in reality it is a for-profit center conducting experiemental procedures. If it were a real clinical trial, the patient would get paid, not the other way around.
Stem cells are an exciting new branch of medicine because when they divide, they can be guided to turn into any type of cell necessary, such as a nerve cell, skin cell or red blood cell, helping to repair parts of the body that have been ravaged by injury or disease. But bone marrow transplants and hematopoietic stem cell transplants are the only stem cell treatments approved in the United States.
“Businesses marketing putative stem cell interventions have proliferated across the U.S.,” the paper states. “This commercial activity generates a host of serious ethical, scientific, legal, regulatory, and policy concerns. Perhaps the most obvious regulatory question is whether businesses advertising nonhomologous autologous, allogeneic, ‘induced pluripotent,’ or xenogeneic ‘stem cell therapies’ are exposing their clients to noncompliant cell-based interventions. Such practices also prompt ethical concerns about the safety and efficacy of marketed interventions, accuracy in advertising, the quality of informed consent, and the exposure of vulnerable individuals to unjustifiable risks.
“Given that many of the businesses we identified market autologous interventions that do not appear to fit FDA criteria for homologous use and minimal manipulation of cells and tissues, allogeneic products, combination products, or ‘xenogeneic stem cells,’ there are clear grounds for concern that some of the companies we found are not compliant with federal regulations,” the paper adds. “There are related ethical concerns about information provided to prospective clients and the veracity of marketing claims, the safety and efficacy of advertised procedures, and the risk of physical, emotional, and financial harm to already ill or injured and vulnerable individuals. Recent draft guides issued by the FDA provide increased clarity concerning how the FDA interprets federal regulations applicable to the use, sale, and distribution of stem cell products. These draft guidance documents suggest to some observers that the FDA is preparing to take increased regulatory action in response to businesses selling stem cell interventions in a manner that some critics have described as exhibiting a ‘Cowboy Culture.'”