The FDA issued a historic statement today promising to more clearly define its regulatory policies on stem cell therapies and to take strong action on some stem cell clinics that it views as “bad actors”. I’ve never the FDA use such clear-cut language before. I give big kudos to new FDA Commissioner Scott Gottlieb.
It already took some action too on clinics in Florida and in California. So today we heard about both a bold statement of vision on how the FDA will deal with stem cell clinics and also it took real action. For instance, the FDA issued a warning letter to Kristin Comella of US Stem Cell Clinic (a subsidiary of US Stem Cell Inc) in Florida, an organization linked to negative outcomes in patients including blindness. It also apparently raided a stem cell business in San Diego, StemImmune Inc.
This taken together is a very big deal. For me as someone who has been following and trying to make a difference about the stem cell clinic problem for more than 7 years, I find today very encouraging. Better late than never?
The FDA also indicated today and has suggested before in a blog post by Gottlieb, that it may soften some regulations of stem cell treatments. We’ll have to wait and see how that plays out and what impact it has.
Overall, what does this all mean and what happens next? This story is still breaking so there’s a lot to think about, but on my first run through of it I’ve got 6 major thoughts and questions on today’s development.
- How much further will the FDA go with actual enforcement actions? What we heard about today is a major positive step, but it’s just one step out of many needed along the path toward reining in the out of control stem cell clinic industry. With around 600 stem cell clinics in the U.S., FDA action on just 2 is positive but not enough. More to come?
- Will the FDA define fat stem cells as a drug (or not) in upcoming guidances? If yes, how will it handle the fact that there are hundreds of clinics using fat stem cells without proper licensing and approval of the product/treatment as a drug? If not and fat stem cells are viewed as not necessarily drug products, will the FDA then narrow the scope of permitted applications of fat stem cells used not as a drug to only include homologous use? I.e., “fat stem cells are drugs if used on non-fat-related health problems”? May there be exceptions to that limitation?
- How will the FDA handle non-homologous use of bone marrow cells in the commercial sector? This kind of use is pretty common out there too by clinics. To be clear, some clinics use bone marrow cells in a homologous fashion and without more than minimal manipulation, but I’m not referring here to those.
- Amniotics? Will the FDA work to deal with the growing problem of unapproved, amniotic stem cell offerings? If so, what steps will it take?
- What about networks of stem cell businesses? How will the new FDA under Gottlieb view networks of stem cell businesses such as Cell Surgical Network? This comes to mind because the FDA in its PR mentioned key member of that network as where StemImmune’s unapproved product was administered to patients: “California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California. ” The founders of Cell Surgical Network are listed on its own website as part of the StemImmune Inc. leadership team.
- Will other entities like state medical boards use this FDA action as a spring-board to get off the sidelines and take positive action too? After all, some of the providers at stem cell clinics I’ve talked to over the years often recite a similar mantra that it isn’t the FDA that regulates them, but rather state medical boards. So, state medical boards and other governmental bodies, are you watching and willing to do something? So far state medical boards have mainly stood on the sidelines on the stem cell clinic problem, but that may be changing.
I always looked at lipogems at a purified fat graft, similar to the output from this product Cytori sold a couple of years ago: http://www.puregraft.com/
It seem that Lipogems are not even considered a stem cell therapy because the adipose is not removed just purified. It certainly is not a concentrated mixture of stromal vascular fraction or MSCs. Is that correct?
According to the website the product is “micro-fractured non-expanded adipose tissue intended for autologous use” with the “ability to maintain intact stromal vascular niches which contain mesenchymal cells and perycites”. So, I guess the answer to your question is no. What do you think?
My understanding is that the Lipogems product has not gone through and NDA or IND for any particular indication. The FDA approval is under section 510(k) as a medical device that purifies fat but does not separate out MSCs which is typically done by most clinics with an enzyme and centrifuge. As a result, while Lipogems may pass the “more than minimally manipulated” test, it seemingly would still fail the homologous test for any therapy other than fat grafts. I doubt the FDA would permit the use even for osteoarthritis under current guidance.
From the 501(k)
“The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. ”
https://www.accessdata.fda.gov/cdrh_docs/pdf16/K161636.pdf
Doesn’t the FDA’s reply to Comella already answer question #2? These are exactly the claims being made by all(?) the clinics using adipose SVF are they not?
Also, Lipogems is FDA-approved for orthopedics and several other uses.
We acknowledge receipt of your written response, dated May 16, 2017, and note that it did not address any of the observations identified on the Form FDA 483. Instead, you claim, among other things, that you are not required to comply with the requirements of 21 CFR Part 1271, because your firm qualifies for the same surgical procedure exception at 21 CFR 1271.15(b). The same surgical procedure exception applies to an establishment that removes HCT/Ps from an individual and implants “such HCT/Ps” into the same individual during the same surgical procedure. Among other things, the HCT/Ps your firm removes from individuals (adipose tissue) plainly are not the HCT/Ps that are used (SVF) following processing by various means (e.g., (b)(4) or (b)(4)). Therefore, your firm does not qualify for the same surgical procedure exception.
You also claim that your product is exempt from regulation “because the procedures practiced at USSC do not involve more than ‘minimal manipulation.’” As detailed above, your product does not meet this criterion set forth in 21 CFR 1271.10(a) (1), because your processing alters the original relevant characteristics of the adipose tissue relating to the tissue’s utility for reconstruction, repair, or replacement.
You further state that your firm’s manufacture of the SVF product falls within the practice of medicine and beyond FDA’s jurisdictional reach. As explained, your SVF product is a drug as defined in section 201(g) of the FD&C Act and a biological product as defined in section 351(i) of the PHS Act. FDA is charged with enforcing the FD&C Act as it applies to FDA-regulated articles such as your SVF product.
Good point, Bill. It’s been a crazy day as I’m also doing a Reddit AMA on stem cells on CRISPR. The FDA’s language in that response is quite direct and clear.