Case could set precedent for regulating stem cells

On, Gergana Koleva digs deep into the ongoing court battle between Regenerative Sciences and the FDA over the question of whether stem cells “should be federally regulated as drugs.” While the treatment at issue isn’t generally a matter of life or death, the courts’ decisions in this case will have implications for other headline-grabbing stem cell treatments.

Human embryonic stem cells

(Photo: National Institutes of Health)

At the heart of the debate is a therapy that uses stem cells derived from bone marrow to repair damaged joints. It was developed in 2005 by the Colorado-based company, which began offering it to patients around 2007, and has since gathered a raft of clinical evidence and testimony about its safety and efficacy. The FDA is questioning its legality, alleging that the stem cells it uses are more than minimally manipulated drugs and should be regulated and subject to approval as drugs. In 2008, the agency accused Regenerative of practicing medicine without a license required for the introduction of a new drug, and in 2010 sued to stop it from performing the procedure.

Regenerative and its allies argue that, because the therapy re-injects a patient’s own cells, it creates, as Koleva writes, “fewer and less severe complications than the more invasive and costlier surgical procedures it helps many patients avoid.” For its part, the FDA calls the therapy unproven and not guaranteed to be safe. In the end, the FDA indicates, it boils down to semantics.

Regulators have argued that the Regenexx procedure is equivalent to the administration of a drug because the stem cells that are re-injected into patients constitute an “‘article’ that is intended to treat, cure, and mitigate diseases and to affect the structure and function of the patient’s body,” therefore fitting within the definition of “drug.”

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