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FDA seeks to shutdown two rogue stem cell clinics

14 May 2018
Appeared in BioNews 949

The US Food and Drug Administration (FDA) is seeking to shut down two clinics offering treatments based on stem cells.

The regulator filed permanent injunctions in federal court last week against the clinics for marketing unapproved stem cell products and for failing to comply with manufacturing guidelines.

FDA Commissioner Dr Scott Gottlieb said: 'The FDA will continue to take enforcement actions against clinics that abuse the trust of patients and endanger their health with inadequate manufacturing conditions or by purporting to have treatments that are being manufactured and used in ways that make them drugs under the existing law but have not been proven safe or effective for any use.'

The US Stem Cell Clinic LLC of Sunrise, Florida, was sent a warning letter from the FDA in August last year about its unapproved stem cell treatments. The current injunction is being sought for the clinic's failure to 'address the violations outlined' and 'come into compliance with the law'.

The other clinic, the California Stem Cell Treatment Centre and affiliates, was the subject of a raid by US marshals in August last year, when five vials of a vaccine against smallpox were seized. These vaccines were being used to create an unapproved stem cell product for administration to cancer patients.

Both clinics were using patients' own fat tissues to produce the unapproved treatments. The FDA said there was evidence that both were failing to follow good manufacturing techniques to ensure sterility, which could put patients at risk of infection.

Three patients lost their sight in 2015 after material extracted from their fat (so-called stromal vascular fraction) was injected into their eyes at the US Stem Cell Clinic in an attempt to treat degenerative eye conditions (see BioNews 893).

The affected clinics have indicated they intend to fight the injunctions. They argue that since the patients' own cells are used, no new drug is created and so FDA approval is not necessary.

According to the Washington Post, Dr Kristin Comella, chief scientific officer of the US Stem Cell Clinic, said in a statement: 'I remain steadfast that no government agency should deprive individuals of their right to harness the cells that exist in their body.'

The FDA said it has aimed to strike a balance between allowing safe and legitimate stem cell therapies to be pursued and approved, while also protecting the public from unproven and potentially hazardous treatments and the clinics supplying them. 'We support sound, scientific research and regulation of cell-based regenerative medicine, and the FDA has advanced a comprehensive policy framework to promote the approval of regenerative medicine products,' said Dr Gottlieb.

Greater control over such clinics by the FDA has been urged before (see BioNews 820). However, some fear that the scale of the issue means that this regulation will not be effective. Dr Peter Marks, director of the FDA's Centre for Biologics Evaluation and Research, told the New York Times: 'There are hundreds and hundreds of these clinics. We simply don't have the bandwidth to go after all of them at once.'

SOURCES & REFERENCES
FDA Moves to Stop Rogue Clinics From Using Unapproved Stem Cell Therapies
New York Times |  9 May 2018
FDA seeking to stop procedures at two unregulated stem cell clinics
STAT |  9 May 2018
FDA seeks injunction to stop two stem cell companies after patients blinded
Washington Post |  9 May 2018
FDA seeks permanent injunctions against two stem cell clinics
US Food & Drug Administration |  9 May 2018
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