My original plan for this post series was going through the FDA’s Warning Letter issued to Ms. Comella, Chief Scientific Officer of the US Stem Cell Clinic (USSCC), on August 24th to review adverse findings the FDA published on the conditions and quality issues they found during their auditing visits.
However, I will spare you the somewhat pedantic review for now that would be required to sort out what appears to be serious problems detected by the FDA in Comella’s clinic and its provision of stromal vascular fraction (SVF) therapy. Instead, I want to focus on what has to be one of the most brazen rebuttal letters made public in response to an FDA Warning Letter that I can recall, signed by K. Comella, which she offered up as a defense of her methods of working with a patient’s own fat tissue to produce SVF.
The letter is rather long and repetitious, but perhaps convincing if you buy into Ms. Comella’s bit about “my body, my cells”. Since I try to remain firmly rooted in reality, which is why I am a somewhat boring scientist, I found her letter to be a real scream. Instead of going line-by-line or section-by-section, which would take me to the end of the year to deal with all of the tautologies and contorted thinking, I will focus on answering the 12 questions that appear at the end of her diatribe. I will present her questions exactly as written.
Here are Ms. Comella’s questions and my answers:
Comella Question One: “Why would bone marrow in-clinic procedures be regulated differently than fat and/or stromal vascular fraction?”
My Response: This is an easy one Ms. Comella, since you just need to look at 21 CFR 1271.3(d) subsections 2 for blood and 4 for bone marrow. This is the excerpt (edited):
The following articles are not considered HCT/Ps:
(2) Whole blood or blood components or blood derivative products subject to listing under parts 607 and 207 of this chapter, respectively;
(4) Minimally manipulated bone marrow for homologous use and not combined with another article (except for water, crystalloids, or a sterilizing, preserving, or storage agent, if the addition of the agent does not raise new clinical safety concerns with respect to the bone marrow);
So, the FDA declared by definition that bone marrow and whole blood would not be included in the 1271 rule, which means these materials are not regulated in the same way as materials like fat tissue and SVF, since those materials definitely are HCT/Ps. However, note that if you want to avoid the requirements of 1271 when working with bone marrow, it has to be minimally manipulated and for a homologous use.
Comella Question Two: “Is fat which has been mechanically broken down (i.e. the LipoGems procedure) instead of enzyme digestion regulated differently?”
My Response: This also is a relatively easy one, since the Lipogems system is cleared through a 510(k), so see the FDA letter to Lipogems (K161636) issued at the end of last year. The point though is that their indication for use is limited to fat grafting, regardless of the surgical specialty in which it is used. I am pretty sure the laundry list of conditions you posted on your website as being treatable with SVF doesn’t apply to being treated by the output of a Lipogems’ procedure (what I call fuzz balls). And injecting fat-containing anything into a joint to treat osteoarthritis isn’t considered homologous use by the FDA either, despite Lipogems’ 510(k) clearance. I went through the reasoning behind the regulatory limitations of the Lipogems system in a previous post on the Greyledge Blog.
Comella Question Three: “Will you allow clinics who are using bone marrow to continue to treat patients?”
My Response: I am not a part of the FDA, but I suspect if the FDA were to provide an answer it would be: Yes. The reason being that bone marrow-derived therapy is exempt from the provisions of 1271, and the FDA has enough on its hands dealing with all of the SVFing clinics. But in case you are thinking of switching over to bone marrow concentrate (BMC) therapies, keep in mind those pesky terms “minimal manipulation” and “homologous use”. I am sure these terms are being used by the FDA as they go through the Internet looking for naughty and nice regenerative medicince clinics. Using BMC to treat your list of pathologies probably would put you back on the regenerative medicine naughty list. Just sayin’.
I will continue in the next post to address the questions included in Comella’s response to the FDA’s Warning Letter.