FDA Warns Doctor Over Stem Cell Company

The FDA has sent a warning letter to a company charging that its adipose-derived stem cell treatments — known as stromal vascular fraction (SVF) — are both a drug and a biologic and need to be regulated as such.

The letter is addressed to Florida-based Mother Stem Institute founder Alvaro Skupin, MD.

Mother Stem appears to have garnered the agency’s attention in part because of claims on its website that its SVF product can treat Alzheimer’s disease, type 1 and 2 diabetes, lupus, and rheumatoid arthritis, despite a lack of evidence for those claims, Paul Knoepfler, PhD, a stem cell biologist at the University of California Davis, wrote in a recent blog post.

“One thing that stood out to me was the marketing of [SVF] for a variety of conditions,” Knoepfler wrote in the post. “For instance, the firm has at times marketed SVF for Alzheimer’s. I don’t believe there’s good clinical trial evidence to back that up.”

Knoepfler added that Mother Stem Institute recently settled a lawsuit brought by a patient who alleged to have lost their vision after visiting the institute.

Notably, the 9th Circuit Court of Appeals recently ruled that SVF is a drug, giving the FDA authority to regulate it across the U.S. Indeed, an earlier ruling against a different Florida clinic — U.S. Stem Cell Clinic — also determined that SVF was subject to FDA regulations.

Knoepfler called the recent 9th Circuit ruling “the biggest FDA stem cell news in a few years,” as there are now two federal court precedents that SVF constitutes a drug.

However, the federal ruling arrived weeks after the warning letter to Mother Stem, which Knoepfler said was “notable” given the “uncertainty surrounding oversight of SVF and lab-grown adipose cells more generally related to the pending appeal.”

“There are scores of firms marketing SVF for dozens of health conditions,” he wrote. “It’s possible the FDA focused its attention on this firm now because of the patient injury alleged in the lawsuit.”

FDA said Mother Stem’s product doesn’t qualify for the agency’s human cell, tissue, or cellular or tissue-based product (HCT/P) exception because it doesn’t meet “homologous use” or “minimal manipulation” criteria. It removes the adipose tissue and processes it, making it a different product when it’s later given to patients, FDA said.

In addition, the agency said it considered the company’s SVF product a misbranded drug because it “fails to bear adequate directions for its intended use(s),” which it defines as detailed instructions that a layperson can easily follow so the product is used safely and for its intended purpose.

The agency requested that the company begin an investigation into these violations and quickly correct any issues. It also advised the company to “comprehensively review” its website and other marketing or labeling material to ensure it is marketing its products lawfully and in full compliance with FDA regulations.

At the time of publication, Mother Stem Institute’s website was not working, and MedPage Today was not able to contact the company for a comment.

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