July 3, 2022

FDA tries to muscle in on stem cell regulation

Colorado clinic fights back

Christopher Centeno, medical director of Regenerative Sciences.The US Food and Drug Administration has
embarked upon a legal battle to extend its authority over stem cell treatments.
It has enjoined a Colorado company, Regenerative Sciences, from treating
patients with stem cells from their own bone marrow or synovial fluid. These
are being injected to treat fractures, torn tendons and other ailments. The
clinic charges patients US$7,000–9,000 and does about 20 procedures every
month.

Christopher Centeno, the medical director
of the company, is ready for a fight. He disputes the FDA’s jurisdiction. Since
the company uses a patient’s own cells, as IVF clinics do, it is none of the
FDA’s business.

Both sides realise that the case could be a
landmark decision. Conventional stem cell researchers are wary of shady operators
who claim therapeutic benefits for stem cells without much research. Douglas
Sipp, of the International Society for Stem Cell Research, worries about what
will happen if Centeno’s company wins in the courts. “Companies would
likely feel empowered to ignore requirements for demonstrable safety and
efficacy of autologous medicinal products, creating an ‘anything goes’
atmosphere,” he told Nature.

And Centeno agrees: “If we win, the
entire regulatory structure for autologous cell processing, with or without
culture, will be rewritten such that any physician using good practices and
treating patients responsibly can use stem cells as part of his or her medical
practice,” he says. ~ Nature, Aug 17



Michael Cook
commercialization
stem cells