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FDA mounts legal challenge to stop treatment at US stem cell clinic

23 August 2010
Appeared in BioNews 572

The US Food and Drug Administration (FDA) has demanded a federal injunction from the US District Court of the District of Columbia to stop Regenerative Sciences (a Colorado based stem cell clinic) from using patients' own stem cells as medicinal treatment.

The treatment involves isolating, culturing and processing adult stem cells from the patient's own bone marrow or synovial fluid. The processed cells are then injected to treat injuries such as fractures and torn tendons. According to the FDA, such treatments are regarded as drugs under the Federal Food, Drug and Cosmetic Act, and Biological Products under the Public Health Service Act. Although the FDA relayed this to Regenerative Sciences, the company failed to apply for FDA approval, and has continued to offer the stem cell treatment. This, says the FDA, constitutes poor manufacturing practice, further compounded by the fact that the safety and efficacy of this therapy is unproved.

In response, Mr Christopher Centeno, Medical Director of Regenerative Sciences, argues that the treatment in question is comparable to IVF, and therefore outside the FDA's jurisdiction. Additionally, Mr Centeno claims that not only does the treatment have a better safety record than regular surgical procedures; it has in fact been proven effective in animal and imaging studies.

However, none of this has assuaged the FDA's demand for evidence from clinical trials. While Mr Centeno agrees with the validity of this demand, he believes there are alternative routes to safe regulation. Namely, following the International Cellular Medicine Society guidelines (ICMS) - of which he is co-founder and Medical Director.

For Mr Centeno and his supporters, the FDA's demand for an injuction is another phase in the long-running battle over the regulation of stem cell therapy between the pharmaceutical industry and clinics. Yet Mr Centeno remains hopeful: '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'.

However some, including Douglas Sipp of the RIKEN Centre for Developmental Biology in Kobe, Japan (and a member of the International Society for Stem Cell Research Task Force on Unproven Stem Cell Treatments), believe that 'the consequences could be severe' if Regenerative Sciences emerge victorious. He says: 'Companies would likely feel empowered to ignore requirements for demonstrable safety and efficacy of autologous medicinal products, creating an 'anything goes' atmosphere... It would be, as they say, a bad thing'.

The court case is likely to begin next summer.

FDA challenges stem-cell clinic
Nature |  17 August 2010
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