Stem Cell Treatment = Drug

A US federal court rules that procedures in which a patient's own stem cells are extracted, manipulated, and reinjected should be regulated by the FDA.

Bob Grant
Bob Grant
Jul 30, 2012

After years of legal wrangling, the US District Court in Washington, DC, last week upheld the Food and Drug Administration's power to regulate adult stem cell treatments in which the cells are more than "minimally manipulated" before being injected back into the patient. The court ruled that the FDA was operating within its legal mandate when it filed suit against Colorado-based stem cell treatment clinic Regenerative Sciences in 2010 to stop them from extracting, processing, and then reinjecting patients' own bone marrow stem cells to treat bone and joint disorders.

The FDA argued that the treatment fell under its purview and was subject to approval like any new drug because the extracted cells were significantly modified using reagents that cross state lines. Regenerative Sciences disagreed, characterizing the treatment as a simple medical procedure, which don’t require FDA approval. The court sided with the FDA, making similar stem cell clinics popping up in the United States take notice. University of Minnesota bioethicist Leigh Turner told Nature that the ruling was spot on. "It is much too simplistic to think that stem cells are removed from the body and then returned to the body without a 'manufacturing process' that includes risk of transmission of communicable diseases," he said. "Maintaining the FDA's role as watchdog and regulatory authority is imperative."

But Chris Centeno, Regenerative Sciences' medical director told Nature that the clinic plans to continue offering patients 3 of its 4 stem cell treatments, in which cells are only processed for 2 days before reinjection. He added that the company will continue to treat patients using the process now prohibited by the FDA in a clinic located in the Cayman Islands and that Regenerative Sciences plans to appeal the court's ruling.