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FDA Cracks Down On Clinics Hawking Unproven Stem Cell Treatments

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The US Food and Drug Administration is taking steps to crack down on disreputable clinics marketing unproven stem cell treatments.

Stem cell treatments have seen a sudden surge in popularity in recent years, with hundreds of clinics opening across the country. However, many of these have not been approved by the FDA, and may even prove to be dangerous, NPR reports.

FDA Commissioner Scott Gottlieb said,

There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt assurances to patients based on unproven and, in some cases, dangerously dubious products.

The agency has already taken action in California and Florida, sending warnings to clinics such as the US Stem Cell Clinic in Sunrise for “marketing stem cell products without FDA approval and significant deviations from current good manufacturing practice requirements.”

The clinic is one of many that tout using stem cells taken from a patient’s fat to treat everything from Parkinson’s disease to amyotrophic lateral sclerosis or ALS.

The FDA has also taken measures to “prevent the use of a potentially dangerous and unproven treatment” by StemImmune Inc. in San Diego. The US Marshals Service confiscated five vials of live vaccinia virus vaccine that was being used as a stem cell therapy supposedly for cancer. The FDA said, “The unproven and potentially dangerous treatment was being injected intravenously and directly into patients’ tumors.”

While the owners and medical staff at the stem cell clinics have stood their ground that they have been helping patients and have been adhering to industry standards, stem cell researchers have praised the FDA for its efforts.

George Daley, dean of the Harvard Medical School and a leading stem-cell researcher, said, “This is the right thing to do.” He said that the FDA is providing guidance for legitimate stem cell treatments while cracking down on “snake-oil salesmen” who make a profit off unproven therapies.



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