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California clinic to perform stem cell procedure amid FDA lawsuit

06 February 2012

By Maria Botcharova

Appeared in BioNews 643

A clinic in California has announced that its doctors are licensed and trained to carry out a stem cell treatment for chronic pain. Meanwhile, the US Food and Drug Administration (FDA) is pursuing a lawsuit against Regenerative Sciences, the company that developed the technique.

Regenerative Sciences claims that the procedure, called Regenexx, is an alternative to potentially painful surgery for injuries such as bone fractures and torn tendons. Doctors take stem cells from the bone marrow of a patient, and process them in a solution, so that they strengthen and multiply. They are then injected into the injured joints, helping to rebuild damaged tissue.

The FDA states that stem cell treatments are a type of medication, and so fall under its jurisdiction. It says the safety of the procedure has not been sufficiently tested, and inspections showed that facilities offering the treatment do not meet its standards. It has insisted that Regenerative Sciences stop performing the Regenexx procedure until the case is resolved.

Regenerative Sciences counter that because stem cells are produced by the body, they are not drugs, so the treatment does not need FDA approval. The group claims to have treated more than 1,000 patients and spent over $500,000 on testing. Regenerative Sciences also point out that the California clinic uses a modified version of the technique that does not include a growth enhancer, a crucial part of the FDA's lawsuit.

Dr Christopher Centeno, director of Regenerative Sciences, says that the FDA is pursuing the case because it fears that Regenexx will become a successful alternative to pain medication, and threaten the FDA's control of a lucrative market. 'Unfortunately, in many cases, it's the clients suffering the most that we can't treat now', he told 5280 - the Denver Magazine.

However, Professor George Muschler, an orthopedic surgeon at Case Western Reserve University in Ohio is concerned by the medical risks of Regenexx after reviewing the published case studies. The procedure 'may be degenerating into an undisciplined and unfocused and even groping and wishful fishing expedition', he told ABC7 News.

The FDA's lawsuit was filed in August 2010 but may not reach a federal court until 2013.

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