Some stem cell clinics respond to Cell Stem Cell paper with ‘not me, them’

Not Me stem cells

There has been relatively limited response from clinics themselves to the Cell Stem Cell paper that Leigh Turner and I published recently on the scope of the stem cell clinic industry in the U.S. Not Me stem cells

We found 570 stem cell clinics and there could easily be 50-100 more that escaped our search methods or that have popped up since we finished our search at the end of February. While not all the clinics necessarily require FDA approval depending on the type of stem cells and the uses, it seems almost certain that many should have gotten approval from the FDA for what they are doing before they started selling the unproven “treatments”.

One thing I was curious about before our paper even came out was what kind of response, if any, it would get from the stem cell clinics. It’s been pretty quiet from that quarter.

A few clinics talked to reporters who covered the paper and basically used some version of the same mantra, “not me, them”. This reminds me of the Family Circus “not me” cartoons (part of one is shown above).

Overall American stem cell clinics are in an awkward situation because on the one hand they want and need the attention of patients in order to make money, but on the other hand the clinics generally do not want critical attention or notice from regulators such as state medical boards, the FTC, or the FDA.

In the long run for some U.S. clinics, just saying essentially “not me, them” won’t cut it. Not everyone in this entire clinic industry selling unapproved and unproven stem cell therapies can be a “not me” unless of course the FDA never takes any real, meaningful, and proportionate action.

The more important question beyond what the clinics think is what the FDA thinks (the agency is aware of our paper) and what will they do if anything about this clinic industry situation? Doing nothing is no longer an option.

FDA?

10 Comments


  1. I have conversed with some of these clinics and also visited several. Many do provide valuable and healing therapies. In my opinion, the FDA would better serve our country by adopting the Australian Model. There doctors are allowed to extract stem cells from fat and then these are sent to an approved and central facility for isolation, purification, testing and expansion (i.e. Magellan Stem Cells). The overall results for patients have been, in many cases, astounding. Rather than doing nothing, the FDA should consider this model. They could approve clinics using “best practices” and also audit and approve cell processing center. We have the pieces out there now they need to be assembled wisely.


    • GMPs do not address the underlying absence of information on how specific cells can be expanded safely and not give rise to untoward and dangerous side effects.


    • @ Peter W Schuster
      “Many do provide valuable and healing therapies”
      “The overall results for patients have been, in many cases, astounding”
      Can you provide me with links to publications or clinical data supporting this? Validating data for these clinics is almost impossible to find here in the US, so maybe reporting is better in Australia?


  2. I have M.S. I had stem cell treatment in Germany in 2003, the doctor extracted 20 vials of cells from my bone marrow then bred many more in a lab before they were re-infused into my spine via a spinal tap and some injected into my blood.

    He was very skilled and the entire process was simple, hygienic and quick (extraction about 30 minutes then 1 hour for reinfusion).

    This is an efficient, safe relatively painless method of obtaining large numbers of the correct cells and far more efficient than trying to extract them from fat IMHO.


    • My treatment occurred in 2003, the cost for stem cell extraction/reinfusion was $10,000 USD, travel between Melbourne Australia and Cologne Germany plus meals, accommodation for a week was $10,000 USD.

      I don’t know if the doctors who performed this treatment are still operating, I couldn’t find them last time I looked. The main doctor was from Tajikistan originally, he was very skilled but I can’t remember his name.

      Kind regards Cathy


    • @admin “A few clinics talked to reporters who covered the paper and basically used some version of the same mantra, “not me, them”. This reminds me of the Family Circus “not me” cartoons (part of one is shown above).”

      Please provide evidence to support this claim, otherwise, retract it.

      (I’m sure you have evidence but making such a claim without it is far from “scientific”.

      Thanks.

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