Court affirms FDA can regulate autologous stem cell therapies

A recent US District Court decision puts the FDA in a better position to impose order on the growing market for stem cell therapies that attempt to treat disease using a patient’s own cells.

Regenerative Sciences, a Colorado company whose product line includes an unapproved treatment for joint pain, argued that its products are not drugs, and that procedures involving the administration of a patient’s own stem cells fall within the boundaries of routine medical practice. These arguments were central to the case because FDA does not have a mandate to regulate the practice of medicine. Its oversight of medical and consumer products is limited to commercial products that meet specific regulatory criteria.

The court disagreed with Regenerative Sciences, upholding an injunction brought by FDA against the company in 2010 and affirming the agency’s right to require that autologous stem cell products meet the same safety and quality standards as any other drug or biologic. To date, only one stem cell product has received FDA approval.

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