Seattle clinic uses FDA commish in marketing non-FDA approved stem cells

How far will stem cell clinics go to market their non-FDA approved “treatments” that they often claim will have miraculous results?

I’ve never seen anything quite as striking as what some clinics in the Seattle area are now doing.

In the past, we’ve seen clinics take researchers’ pictures, quotes, or videos to use for their own marketing. In the last 1-2 years we’ve seen increasing numbers of mainstream media ads for clinics too (see here and here, for example) so the clinics are thinking spending a lot of money on ads is a good strategy. Some clinics also succeed at getting listed on Clinicaltrials.gov even though they mostly aren’t doing IND-based clinical trials.

They’ve been busy!

However, the latest seems particularly striking. Two related Seattle area stem cell clinics are oddly enough marketing their apparently non-FDA approved offerings, using a quote from the new FDA Commissioner, Dr. Scott Gottlieb (a hat-tip on this to Dr. Erica Jonlin of the UW in Seattle.)

In their ad in the Seattle Times (above) and on their website, adipose stem cell clinic Generation Stem Cell is using part of a quote from Gottlieb that expressed his general excitement about stem cells and regenerative medicine. Did Generation Stem Cell get the FDA’s or Gottlieb’s permission to use his quote in their ad? I strongly doubt it.

Perhaps not surprisingly the business doesn’t quote some of Gottlieb’s other, very different recent statements on stem cells including this one about the direct-to-consumer stem cell clinic arena:

“Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science. In such an environment a select few, often motivated by greed without regard to responsible patient care, are able to promote unproven, clearly illegal, and often expensive treatments that offer little hope, and, even worse, may pose significant risks to the health and safety of vulnerable patients.”

To be clear, I don’t know if Gottlieb would view Generation Stem Cell as a “bad actor” and I’m not making any allegations about this business. However, there are some issues here warranting questions and discussion.

Like a large number of stem cell clinics across the U.S., again as best as I can tell this firm doesn’t have FDA approval for their adipose stem cell treatments (see more below) and based on recent FDA finalized guidance, adipose stem cells are most often going to be drugs requiring pre-market approval. So is Generation Stem Cell compliant? I tried to learn more from their website.

On the site they have a FAQ section including this question, “Is stem cell therapy FDA approved?” I found their answer to this one to be rather surprising:

“No, stem cell therapy is too new to be approved by the FDA. However, the FDA does have guidelines about treatment and manipulation of a patient’s own tissues. The Generation Stem Cell procedures and protocols meet those stringent guidelines.”

Is “too new” to be approved by the FDA a thing? I don’t believe so.

I’d also ask the clinic, “Have you read the new finalized FDA guidelines including relevant sections on adipose stem cells? Why are you so confident about your clinic meeting the FDA’s guidelines? Has the FDA said specifically to you that you meet their guidelines?” If the clinic has good answers to these questions, I hope that they let me know and I’ll post them.

Generation Stem Cell makes some medical claims in their ad and on their website too including for patients to become “pain-free” and invoking some kind of “miraculous ability” of fat stem cells to repair damage (see my red circle highlighted text in the screenshot from their website). What is the basis for these claims? Is there hard, peer-reviewed data?

Like many other clinics, this place also is offering promotional seminars via their ads to attract new customers. Their website also seems to indicate an affiliation with two other nearby clinic-like entities: Bellevue Pain Institute and NW Pain Relief Centers as you can also see their logos in my screenshot. The former firm itself mentions miraculous effects and quotes Gottlieb too on their site.

Bellevue Pain Institute announced on their website that they are now part of Cell Surgical Network, a large, affiliated group of stem cell clinics selling non-FDA approved adipose stem cell offerings across the U.S. and abroad. Some important medical claims are made on their site too, including of 100% safety:

“Within the Cell Surgical Network over the last 7 years we have performed well over 7000 recorded and tracked adipose derived stem cell procedures and have recently published our safety study showing 100% free of significant side effects.”

One important thing I don’t see on the Generation Stem Cell and NW Pain Relief websites is mention of the specific physicians or other care providers who will be conducting the stem cell procedures. Maybe I missed it. The Bellevue Pain Institute mentions its providers here, including chiropractors and at least one naturopath. Note that we are seeing more naturopaths offering stem cells in 2023 including Docere Clinics.

Are the providers listed qualified to be giving stem cell transplants? If so, how so?

In the bigger picture, there are clear indications that the for-profit, direct-to-consumer stem cell clinic industry continues to expand across the U.S.  Although the FDA has given some encouraging signs about their awareness of the importance of proper oversight of this industry, more needs to be done including concrete steps. Every day I would estimate that many hundreds if not thousands of people are receiving (and paying large sums of money for) unproven, experimental, and non-FDA approved stem cell injections in the U.S. alone. Consumers are being drawn to the clinics via ads and websites like those discussed in today’s post.