May 30, 2020

The Niche

Knoepfler lab stem cell blog

Sales of ‘zombie’, birth-related ‘stem cells’ continue to mushroom

The birth-related stem cell clinic industry is a serious problem for patients, the stem cell field, and the FDA as the clinics sell more and more of what I think of as “zombie” injections.

One of the biggest changes in the last 2 years in the unproven stem cell clinic arena was predicted by the data that Leigh Turner and I published in one of our collaborative papers in which we saw an upward slope in the number of businesses selling amniotic or other birth-related “stem cells”.  By “birth-related” I mean amniotic, placental, umbilical cord, or other products that result from the birth of a new baby.

The numbers were still very small at the time of our study, but the trend was clear. Still, at that point I wouldn’t have guessed that we’d find ourselves in early 2019 with a massive number of clinics selling birth-related “stem cells” from coast to coast. There could easily be 100-200 of these clinics or other individual practitioners selling this stuff. Why the big growth here? Suppliers and marketers are driving the expansion by convincing chiropractors (and some physicians) to sell their unproven and non-FDA approved products.

Zombie

I speculated in a post “Wanted Dead & Alive” a couple of years back that some for-profit clinics and suppliers in this area are selling products that aren’t really living stem cells (they are “dead” extracts), but they still market the products as both living and stem cells. Hence, there’s my opinion that this is a “zombie” kind of thing.

To be clear, some birth-related products (when not in vague “zombie” form, but instead produced in appropriate clinical-grade facilities by experts and validated to contain living cells of defined types) are promising for certain applications and are being studied in many clinical trials, but should not be sold today.

There are big, unanswered questions here. For instance, where do the birth-related products come from? How often are they either be contaminated or have not been probably tested for pathogens? Do the new mothers know that the materials from the births are being sold and possibly resold? Is it possible in many cases mothers have not consented to the use of the brith-related materials?

Also, could some of the products sold in the US be produced from overseas births? I have heard this is likely the case for some suppliers, but I haven’t seen concrete evidence of this. The lack of clarity about the sourcing and validation of birth-related products being widely injected into patients is very worrisome.

For instance, in the last few months we learned that 12 people were reportedly hospitalized due to contamination of a birth-related product being marketed by Liveyon and apparently produced by another firm called Genetech (not Genentech). Somehow the product became contaminated (or was contaminated to start with?) with various kinds of bacteria before it was injected. Fortunately for other potential patients, the product was recalled by the FDA.

This doesn’t seem to have made much of a dent in this birth-related “stem cell” clinic sector so far, but we’ll see. There also have been at least two and perhaps more patient lawsuits against firms in this area. I expect that number is already growing and that could rein things in somewhat too.

The FDA needs to get moving in this area since the products are marketed as living cells, which in allogeneic form and often used in a non-homologous manner would be unapproved drug products. If there are no real living stem cells in most of these products as many of us suspect, then the FTC needs to take some action here quickly too.

Paradoxically chiropractors are the primary ones selling birth-related ‘stem cells”, even though they themselves cannot legally inject them. In my opinion, these chiropractors pitching stem cells are essentially working with suppliers and physicians to just extract more money from their client base, without a reasonable expectation of benefit to the customers and with definite risks. Chiropractic associations needs to take some kind of major action here.

Overall, how do we get out of this zombie, birth-related “stem cell” mess?

The possible solution seems to be a combination of educational outreach to patients/consumers and bold action by multiple levels of regulators. It’s not encouraging that in the fat stem cell clinic arena, which is even bigger as well as being years older, and has some major problems of its own including hurt patients, we haven’t seen this kind of big impact yet by regulators.

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