Human Exceptionalism

Adult Stem Cell Clinic Moves to Mexico

I am a huge supporter of adult stem cell research. But it needs to be done in the right way. Moreover, research subjects should never be charged for their own experiments as part of a for profit business–which, unfortunately, Texas permits legally–but that is not binding on the FDA.

Now, an adult research center that wants to rush (as yet) unproven regenerative treatments to the clinical setting is moving to Mexico. From the Nature news story:

 

US citizens who had pinned their hopes on a company being able to offer stem-cell treatments close to home will now need to travel a little farther. Celltex Therapeutics of Houston, Texas, stopped treating patients in the United States last year following a warning from regulators. A 25 January e-mail to Celltex customers indicates that the firm will now follow in the footsteps of many other companies offering unproven stem-cell therapies and send its patients abroad for treatment — but only to Mexico.

The stem-cell treatments offered by Celltex involved extracting adult stem cells from a patient, culturing them and then reinjecting them in a bid to replenish damaged tissue. It had been offering the treatment for more than a year — with one of its high-profile customers being Texas governor, Rick Perry — when the US Food and Drug Administration (FDA) wrote to the company on 24 September 2012 advising it that the stem cells it harvested and grew were more than “minimally manipulated” during Celltex’s procedures. As such, the FDA regarded the cells as drugs, which would require the agency’s approval to be used in treatments.

We would expect the FDA to do that if the treatments were embryonic. Adult experiments should be treated no differently.

The slow pace of the FDA can be maddening, but that doesn’t excuse a wild, wild, west approach to medical research–which can be dangerous, non efficacious, expensive, delay a patient from obtaining proven treatments, or all of the above.

Desperate people will take desperate measures looking for cures. It is wrong to take advantage of them. I would advise against traveling to foreign countries in pursuit of unproven treatments. 

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