Be Aware of These Nine Questionable Clinics

John Watson

Disclosures

August 20, 2018

In This Article

Stem Cell Clinics Await FDA Ruling

Unlicensed stem cell clinics have been described as medicine's Wild West. These clinics deal primarily with unapproved adipose-derived stem cells administered in an experimental treatment of undetermined therapeutic value that many believe flaunts the US Food and Drug Administration's (FDA's) rules for what constitutes a biologic agent.[10] Online advertising for stem cell clinics often uses highly misleading language downplaying risks and promoting their curative value for a host of conditions, including multiple sclerosis, aging, Parkinson disease, stroke, and spinal cord injury.[11]

"There is essentially zero concrete evidence from properly controlled studies that what they are selling is safe and effective," said Paul S. Knoepfler, PhD, a professor of cell biology and human anatomy at UC Davis School of Medicine in California and author of the book, Stem Cells: An Insider's Guide.

In a 2016 editorial in the New England Journal of Medicine (NEJM),[12] the FDA took aim at the perceived safety of these therapies. They noted cases where even autologous stem cells—regarded to pose fewer safety issues than their allogeneic counterparts—have led to tumor development and blindness in patients with lupus and macular degeneration, respectively.

If finalized, ongoing FDA draft guidance regarding stem cells[13] may immediately render hundreds of these clinics noncompliant.

"The FDA has signaled [that] it views a common type of fat stem cell prep used by clinics as drugs. None of the clinics have approval to use these drugs," Knoepfler explained. "The FDA has also indicated that using one type of stem cell to treat a very different part of the body (termed 'nonhomologous use') makes stem cells a drug as well. An example of this would be using fat stem cells to try to treat a lung, brain, or heart condition, because these tissues have nothing to do with fat."

In 2018, FDA commissioner Scott Gottlieb, MD, and Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, coauthored a new paper in the NEJM stating their desire to expedite stem cell therapies deemed safe and effective.[14] This led some to wonder whether their commitment to cracking down was loosening.

In a blog post that followed this latest NEJM publication, Knoepfler expressed cautious optimism in the FDA's commitment to enforcing rule changes, while also noting areas of concern.

"With the clock ticking starting in November 2017, FDA has said before and now says again in this new NEJM piece that entities have 36 months to figure out where they stand and get clarity on the guidances," he wrote. "Some of us are concerned that the hundreds of clinics may view that as a 3-year free pass of a sort, which could be a really bad thing for patients and the stem cell field."

For patients who are still curious about this unproven therapy, Knoepfler has provided a guide to stem cells on his blog that will answer most relevant questions.

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