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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.


19 September 2016 - by Dr Lucy Freem 
The US Food and Drug Administration has held a public hearing on proposals to regulate stem cell treatments in the same way as drugs...
30 June 2014 - by Dr Lucy Spain 
A stem cell therapy that is highly successful at keeping race horses in the fast lane is to be trialled in humans for the treatment of Achilles tendinopathy...
23 September 2013 - by Nishat Hyder 
An expert panel of scientists has issued a report advising the Italian Government against continuing to support a controversial stem cell therapy, deeming it 'unscientific'....
07 January 2013 - by Dr Linda Wijlaars 
Bone fragments were removed from the eyelid of a woman after a facelift that used her own stem cells yielded some unexpected results...
30 July 2012 - by Ruth Retassie 
A US federal court has ruled that a stem cell product is classified as a 'drug', falling under the jurisdiction of the Food and Drug Administration (FDA). The ruling allows the FDA to regulate stem cell therapy in the USA and could open clinics that offer stem cell treatments open to federal liability...

17 October 2011 - by Jessica Ware 
A US doctor accused of implanting stem cells into chronically ill patients pleaded not guilty at a court hearing on Thursday 13 October. Dr Ralph Conti, of Henderson, Nevada, has been accused of transplanting stem cells harvested from placental tissue into patients, at the direction of Alfred Sapse, who was falsely claiming to be a doctor....
30 August 2011 - by Ayesha Ahmad 
A US businesswoman from Arizona has been convicted of selling unapproved stem cells over a period of several months....
23 August 2010 - by Nishat Hyder 
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...
22 March 2010 - by Dr Marianne Kennedy 
The ability for mammals to regenerate damaged tissue without scarring has been demonstrated for the first time by a research team based at the Wistar Insitute, Philadelphia...
08 March 2010 - by Harriet Vickers 
A US company has been granted beneficial 'orphan drug' status by the American Food and Drug Administration (FDA) for an embryonic stem cell therapy it's developing to treat a rare form of blindness...

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