The FDA’s campaign against the “bad actors” operating in regenerative medicine is far from complete.
The regulator on Tuesday admonished San Diego-based StemGenex Biologic Laboratories LLC for marketing an unapproved stem cell product and pointed out significant violations that could corrupt the manufacturing process, potentially culminating in microbial contamination that put patients at risk.
The crackdown on clinics selling regenerative medicines for a host of unapproved indications continues to gather steam, as the agency makes good on its 2017 promise to ensure unscrupulous players marketing unproven and often dangerous products are held to account.
The field enticed a growing list of companies that have “opportunistically seized on the clinical potential of regenerative medicine” to make dubious claims to patients that often suffer from incurable, debilitating diseases, the agency underscored in a statement in August 2017.
We’ve seeen, and taken steps to support, major progress in regenerative medicine in recent years. But we continue to see bad actors exploit field’s promise to mislead vulnerable patients about safety, efficacy of treatments. Our latest enforcement action: https://t.co/NSkfEYjfCt pic.twitter.com/Kv3plSoUuZ
— Scott Gottlieb, M.D. (@SGottliebFDA) November 14, 2018
In StemGenex’s case, the FDA found the company was processing body fat into stromal vascular fraction (SVF) — a cellular product — and “illegally” marketing it for serious, often life-threatening diseases, including diabetes, fibromyalgia, spinal cord injury, chronic obstructive pulmonary disease and muscular dystrophy. And they administer it by IV, inhalation and directly into the spinal canal.
This product, which involves more than the minimal manipulation of a patient’s adipose tissue, is regulated as both a drug and biological product, but the agency said that no such licenses or approvals have been sanctioned or applied for.
On the company’s website, its proprietors claim:
StemGenex Stem Cell Research Centre and affiliates do not claim that treatment using autologous stem cells are a cure for any condition, disease, or injury. Adipose-derived stem cell therapy is not a part of FDA approved stem cell therapies and is not a considered a cure for any medical condition. All statements and opinions provided on this website are for educational and informational purposes only and we do not diagnose or give medical advise via this website.
As part of its warning letter sent to StemGenex on October 31, FDA also listed a number of deviations from current good manufacturing practice requirements in the manufacture of the SVF product, including unvalidated manufacturing processes and an uncontrolled environment.
The warning letter is the latest in a slate of warnings issued by the regulator since last year. Last January, the FDA slapped a similar warning on New Jersey-based American CryoStem Corp, in addition to warnings issued to organizations in Florida and California in 2017 to address such products being marketed.
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