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FDA Stem Cell Clinics Crackdown: Agency Targets Unproven Treatment

Image: FDA Stem Cell Clinics Crackdown: Agency Targets Unproven Treatment

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By    |   Wednesday, 30 August 2017 08:54 AM

The FDA is targeting stem cell clinics in a crackdown following recent inspections that revealed certain clinics were administering treatment that were unproven or risky.

"Stem cell clinics that mislead vulnerable patients into believing they are being given safe, effective treatments that are in full compliance with the law are dangerously exploiting consumers and putting their health at risk," FDA Commissioner Scott Gottlieb said in a news release.

Gottlieb said the FDA would crack down on clinics that took advantage of patients or endangered their health with the promise of treatment that may not offer any benefit.

"We will take a firm stance against those that prey on the medical promise of regenerative cell therapies to market treatments potentially unsafe or unproven so-called cures," he said. "We want a regulatory framework that helps efficiently and effectively advance the many promising technologies in the field of regenerative cell therapies."

On Tuesday the FDA posted a warning letter on its website in which it reprimanded the U.S Stem Cell Clinic of Sunrise in Florida for marketing stem cell products under objectionable conditions.

It further explained how the clinic had been making "significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk."

In a separate incident, the FDA swooped down on the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills on Friday.

According to a statement released by the organization, five vials of Vaccinia Virus Vaccine (Live) were seized in an effort to prevent the use of a potentially dangerous and unproven treatment belonging to StemImmune Inc.

The FDA said the vaccine was reserved for people at high risk for smallpox and was not commercially available.

The organization expressed concerns about how StemImmune obtained the product for use as part of an unapproved and potentially dangerous treatment.

University of Minnesota bioethicist Leigh Turner said companies have been making "a wide array of claims about stem cell treatments" on their websites and social media for about five years, the Minneapolis Star Tribune reported.

"I’m a little perplexed as to why it’s taken to this point in 2017 for the FDA to act. But I do think it’s important and it will be interesting to see if there is real enforcement activity," she said.

Some treatments use stem cells from donors, but Dr. Ronald Hanson, founder and chief medical officer of OrthoCure Regenerative Orthopedics clinic, questioned the FDA's oversight of treatments using cells from the patients' own bodies.

"From the physicians who have practiced for a long period of time, it seems fairly heavy-handed to call somebody’s cells ‘drugs,’ " Hanson said, according to the Star Tribune. "I have to tell you, 100 percent of the patients who I have told that to cringe that their government would classify their cells as drugs."

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The FDA is targeting stem cell clinics in a crackdown following recent inspections that revealed certain clinics were administering treatment that were unproven or risky.
fda, stem cell, clinics, crackdown
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2017-54-30
Wednesday, 30 August 2017 08:54 AM
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