R3 Stem Cell still raises red flags for me after FDA letter including do one-get one meeting

Back in May, the FDA cautioned a stem cell clinic firm called R3 Stem Cell and its leader David Greene about what they were doing. Importantly, the agency indicated that some of R3’s stem cells may be unapproved drug products.

FDA and R3 Stem Cell

While the FDA didn’t send R3 Stem Cell a formal warning letter, in my view the agency made it very clear in the “untitled” letter that this firm should make some changes. The letter went out both to R3 Stem Cell and its dozens of affiliates.

(Note that an “untitled” letter from the FDA is generally considered one step below a formal warning letter, but still can indicate serious issues. It’s not always clear how the agency determines whether to send a warning or untitled letter because they can be similar in nature.)

Greene and R3 have been the subject of some recent critical media coverage as well including this recent scathing piece from the Phoenix News Times sparked in part by the earlier in-depth report in The New Yorker/ProPublica from Caroline Chen.

So has anything major changed for R3 since the letter from the FDA earlier this year? There may have been some changes including in the types of stem cells offered (see an update to this post below), but unfortunately, there are still major reasons for concern in my view.

Stem cell courses

For instance, I see red flags in an email I just got from R3 about a stem cell course they are running next week. The current version of their website is concerning in some ways in my view as well.

As to their upcoming meeting, one of the concerns right off the bat for me is that attendees apparently can both learn about how to do some kind of stem cell-related aesthetic procedures and also receive those procedures themselves too at the same meeting.

Is that safe?

More broadly, the R3 website claims to have done more than 11,000 stem cell procedures in the past. How many were FDA compliant? Safe? Effective? I’m skeptical.

Update on cell types:

What do they actually sell in the way of stem cell-related injections? Their website lists six kinds of stem cells or other materials that (see screenshot at right) it seems like they potentially market. That was my reading of things from looking at that part of the website because above the 6 types of offerings it says, “For more information on each of the various stem cell injection options offered at R3 Stem Cell Clinics, simply click on any of the following“.

Doesn’t that strongly suggest that the 6 items below that statement are offered by the firm? What do you think when reading that?

However, if you click on the adipose stem cell link (which I did the day after originally posting this piece) and then also scroll down a ways and look carefully it says they are actually not offering these cells now. So why even still have the fat stem cell link and page?

The R3 website in addition lists many conditions for which stem cells are supposedly going to be used including very serious things like ALS. To my knowledge, there’s no indication that stem cells can safely and effectively help these conditions including ALS. I feel that you shouldn’t market something for ALS and other serious conditions unless you have excellent data on it. That’s not fair to the patients and their families. It’s a bit ambiguous I suppose as to whether R3 is currently taking patients with all these conditions, but that was my interpretation of things based on that webpage.

In the meeting email there was also an infographic featuring Greene and R3 (above), which mentions the key services offered including marketing, patient acquisition, and artificial intelligence (AI). I wonder how patients feel about being viewed as something that can be acquired? And what’s the deal with the reference to AI?

While the meeting is focused on aesthetics, it also mentions treating erectile dysfunction (ED). There is no FDA-approved stem cell-related treatment for ED.

Another notable thing about this meeting is that it is says that somehow Arizona State University is involved or there’s some kind of connection between R3 and them:

“Hands on Regenerative Medical Aesthetics Course Nov 15/16 – Real Patients with Real Biologics! Being held in conjunction with ASU’s Innovation Center at SkySong in beautiful Scottsdale, AZ.”

I’d like to learn more about the reported ASU connection.

In the big picture, despite doing much better in recent years relatively speaking, the FDA has its work cut out for it in overseeing this space. The agency needs to do far more.

Note: This post was updated to clarify some aspects including in particular the types of offerings potentially now marketed by R3.