Friday, March 2, 2012

Nature reports that Celltex is treating patients with unapproved stem cells, possibly in violation of the law

Some alarming news out of Texas, thanks to the investigative reporting of Nature reporter David Cyranoski: even as Celltex has consistently denied that it treats patients with stem cells, it appears that the company has been doing just that, with the help of Houston neurologist Jamshid Lotfi.  Here is what Nature reports:

"Lotfi says that he has administered cells processed by Celltex to more than 20 people. 'Five or six' — including Bertrand — have multiple sclerosis and 'four or five' have Parkinson's disease, he says. Lotfi explains that patients sign up for treatment by contacting Novak, and that cells are prepared by removing about five grams of fat — containing roughly 100,000 mesenchymal stem cells — from the patient's abdomen. Over a three-week period, the cells are cultured until they reach about 800 million cells. Lotfi says that patients get at least three injections of 200 million cells each, and that the cells do not take effect for a few months. According to Lotfi, Celltex charges US$7,000 per 200 million cells, and pays Lotfi $500 per injection."

An accompanying Nature editorial says that "too many people are promising those cures (stem cell treatments) to patients now, long before there is any evidence that they work. These claims are potentially misleading at best, and at worst could be downright harmful."  The editorial goes on to say, "The US Food and Drug Administration (FDA) considers it to be a crime to inject unapproved adult stem cells into patients."

The Celltex "President for Ethics and Strategic Initiatives," Glenn McGee, has tweeted his resignation, and promises an explanation later.  It is hard to imagine what the explanation might be, given that McGee was part of an ICMS investigation of practices very much like this in 2010 by the Celltex partner, RNL Bio.

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