Turbulence! My new pub tracking 100s of stem cell clinics over 3 years

Knoepfler 2019 Regenerative Medicine stem cell clinic study Figure 1
Knoepfler 2019 Regenerative Medicine stem cell clinic study Figure 1

I’m a biologist and genetics researcher, but as I have time I still squeeze in a little research on stem cell clinics when I can, and my new pub in Regenerative Medicine is notable for looking at changes in clinic firms in a unique kind of way.

In the paper I went back to the 351 stem cell clinic firms with their 570 stem cell clinic locations that Leigh Turner and I defined in our 2015-2016 study published in Cell Stem Cell. I looked at where these firms and clinics stand today. How many are still around and how many are gone? Of those still around, how many have given up on stem cells? Have others expanded or shrunk?

Of the ones that are apparently not marketing stem cells anymore, what happened to them?

The pub is entitled “Rapid change of a cohort of 570 unproven stem cell clinics in the USA over 3 years.” I found some big, quick changes. About 1 in 5 of all the 2015-2016 stem cell clinic firms now appear to no longer be in the stem cell clinic business. A large fraction of this 20% no longer have an active website, while the others are still present but did not show clear signs of marketing stem cells any longer.

Knoepfler 2019 Regenerative Medicine stem cell clinic study Figure 1
Knoepfler 2019 Regenerative Medicine stem cell clinic study Figure 1.

As much as someone advocating for the need for IND-based and rigorous trial data-based studies might think that 20% of the 2015-2016 stem cell clinic firms no longer being active 3 years later is good news, the total number of clinics in the cohort actually appeared to modestly increase because some individual firms greatly expanded their number of clinic locations. It was rarer for firms to show a sizable drop in clinic numbers. See Figure 1 where each bar represents a clinic firm still actively marketing stem cells that either grew or shrunk in terms of the number of its locations/clinics from 2015/2016-2019.

Still, despite the moderate increase in total clinic locations in the group, if the data overall due in fact represent a bit of a consolidation of clinics into a smaller number of parent firms, that may represent a relatively easier group to manage for regulators. Then again it’s still a big, complicated cohort. We’ll see.

I also took a look at two popular stem cell clinic “brands”: Cell Surgical Network and Regenexx. How did they specifically change during the 3-year period in question? From the pub:

“Searching by brand, of the 42 Cell Surgical Network affiliated firms (they generally use adipose stromal vascular fraction, which the FDA has defined as a drug product) in the original 2015–2016 published database, a third (14) apparently were no longer actively marketing stem cells in 2019 during the period of analysis. Of these 14, three were still active as businesses or as the same physician but did not appear to market stem cells while the other 11 had inactive websites. The other major stem cell clinic brand identified, Regenexx, which primarily markets what appear to be generally FDA-compliant bone marrow-related offerings for orthopedic conditions, had 24 firms listed in the 2015–2016 database. As of 2019 five of these had inactive websites, although one of these, Harborview Medical, appears to have merged with the larger Regenexx corporation.”

To me that seems like a sizable apparent drop in the active Cell Surgical Network clinics from the 2015-2016 database, while there was relatively less change in Regenexx firms from the 2015-2016 database. However, it’s possible that these brands have entirely new clinic locations so that their full networks did not decrease in size. That’s not a question I addressed here. The paper focuses on examining the state of the previously ID’d clinics firms rather than ID’ing entirely new firms so it doesn’t bring us a new grant total number of clinics in the US either.

My study had some others limitations too including being conducted based on on-line data retrieval (with the exception of a handful of phone calls made to firms to try to clarify their status) and relying on a few looks at the state of each of the clinic firm websites conducted in March-June. Websites can change fairly quickly and it’s possible that after being down for a few months, some could come back up in certain cases. So basically this paper was a snapshot in Spring 2019.

It’s also possible more generally that some of the same firms are still out there using a different URL, but I did try to search for them by business name and I took that into consideration.

Overall, this pub indicates that stem cell clinics are in general a fairly rapidly-changing type of business and many disappear or change over a few years. This makes overseeing this clinic industry harder for the FDA and other agencies like the FTC.

6 Comments

  1. Admin, a couple of questions related to the new pub’s scope. It would be informative to know how many patients are being treating in private stem cell clinics on an annual basis. I have my crude estimate. What is your best guess/estimate?
    Second, did you investigate how many of the private stem cell clinics have advanced to FDA-authorized studies or new efforts to document their treatments and patient outcomes individually or as participants in private clinic consortia?

    James @ Asymmetrex

    • @James, data on patient volume at clinics is scarce and often vague such as statements, “We’ve treatment X thousand patients and never had a problem”. I haven’t really seen statements about yearly patient volume. I’ve tried to make guesses over the years, but it’s difficult and mainly something one can try to do for specific firms that have at least said something about their patient #’s. Also I’d imagine some clinic firms see very few customers such as only a couple a week, whereas others see quite a few per day.
      I have not seen clinic firms get INDs, IDEs, or RMATs recently. There were a few cases in the past. There in theory could have been some in the last few years too but just not in the public domain yet or I missed them.

  2. Thanks for that correction, Bill!
    Of course, in this time of cyber security concerns, maybe Sairam intended “hack a mole”. 🙂

Leave a Reply