A new study sounds the alarm on stem cell treatments in the United States.
Stem cell research represents a bold new frontier in the medical community, but a shocking new study indicates widespread abuse of such treatments in the United States.
In a study published in the journal Cell, two researchers discovered that 351 businesses were openly selling stem cell interventions through 570 clinics in the United States, according to text from the paper.
It is against federal regulations for for-profit companies to market stem cell treatments directly to consumers, especially those who are desperate for a way to beat a terminal illness, but it appears that it’s happening on a regular basis in the U.S. anyway. Websites often appare legit by linking to scientific studies and patient testimonials, and they will often pretend to be clinical trials, but then they will charge patients for the treatment — in the reality, the patient should be paid for being in a clinical trial.
Stem cell treatments are an exciting possibility with many possible medical uses as they can be turned into any type of cell and can help repair organs and parts of the body damaged by injury or disease. But stem cell research is still in its early phases, and right now only bone marrow transplants and hamatopoietic stem cell transplants are 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.'”
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