It feels like I’ve been writing about the Florida clinic US Stem Cell for a very long time. The FDA has been aware of them for about as long.
It was only after reports of patient injuries that the FDA at last took action on US Stem Cell and its subsidiary US Stem Cell Clinic. Several of the clinic’s customers got injections of fat cells into their eyes and reported lost vision. Finally, the FDA filed suit against US Stem seeking a permanent injunction, which was upheld in the courts.
That 2019 permanent injunction enjoined the use of adipose stem cells, sometimes called SVF. Especially after US Stem lost their appeal of the case in mid-2021 it seemed like that might be the end.
But they’re back in the news now in 2023.
New lawsuit against US Stem Cell Clinic and Dr. Antonio Blanco
A new lawsuit filed by a clinic customer Donald Pelton who, according to the complaint, was allegedly seriously harmed by stem cell injections from US Stem Cell Clinic brings it all back again. The suit argues that US Stem Cell Clinic seriously harmed Pelton via an unproven stem cell procedure, which led to a disastrous infection in his body.
What was injected? The firm reportedly isolated Pelton’s stem cell material from the belly button region, per the complaint:
“Dr. Blanco had harvested stem cells from Mr. Pelton’s umbilicus region; the stem cells were cryo-frozen and stored for later use.”
To me that seems most likely to be an adipose stem cell preparation, like stromal vascular fraction or SVF. Mini-liposuctions or similar procedures with syringes typically get fat from this region to start the SVF process. I don’t know of other types of stem cell products where material is first isolated from around the belly button.
The FDA has defined SVF as a drug requiring agency approval, which was at the heart of the agency lawsuit against US Stem Cell. Per the injunction, after mid-2019 my sense is that the firm should not have been using adipose cells or SVF on customers.
US Stem Cell Clinic post-injunction
It seemed that after that maybe US Stem Cell Clinic would try other approaches like bone marrow cells or PRP.
The injunction specified that they could not use SVF, but that left open other options.
Maybe they’d venture into other alternative health approaches too.
I did recently take note earlier this year when US Stem Cell disclosed in SEC filings that it and many others were notified of an upcoming malpractice suit. Is this new lawsuit related to that previous disclosure of impending malpractice suits?
Did injections violate federal court injunction?
The big question is whether Mr. Pelton got SVF or something else.
Part of what makes this situation somewhat tense relates to timing.
As far as I know the injunction on US Stem Cell was active from mid-2019 onward. Yet the complaint says he got one or more cell injections in early 2021 that led to his alleged serious health problems.
Between the time when US Stem lost the initial case and the final ruling by the appeals court in favor of the FDA in mid-2021, was the injunction still in place? That was my impression.
Defendants include Dr. Antontio Blanco
Getting back to the suit, here are the defendants: US STEM CELL CLINIC LLC, US STEM CELL CLINIC LLC d/b/a REGENERATIVE WELLNESS CLINIC, ANTONIO E. BLANCO, M.D., ANTONIO E. BLANCO, M.D., P.A., and MICHELLE PARLO.
The complaint argues that Dr. Blanco was working for US Stem Cell Clinic/Regenerative Wellness Clinic. On the web it says he’s an internist.
Some of you might recall that US Stem Cell used to have a subsidiary US Stem Cell Clinic. It’s hard to follow the history of this firm related to such similar names, but it seems US Stem Cell Clinic eventually became its own company.
US Stem Cell Clinic appears now to be led by former US Stem Cell CSO Kristin Comella per her LinkedIn page.
What is Regenerative Wellness?
It’s a Florida firm that offers or offered stem cell injections. It was mentioned in a press release by US Stem Cell Clinic (emphasis mine):
“The U.S. Stem Cell Clinic of The Villages will offer alternatives to chronic pain management using USRM’s proprietary AdipocellTM product in a minimally invasive procedure utilizing a patient’s own (autologous) stem cells. Medical director for the clinic will be Dr. Rosemary Daly, an interventional spine/pain management physician who is board certified in Anesthesiology and Pain Medicine. Dr. Daly, who graduated from the New York College of Osteopathic Medicine, is also medical director for the Regenerative Wellness Clinic (RWC) in West Palm Beach, which is also in the USRM network of stem cell treatment centers.
“Expansion of our regenerative healing centers to The Villages is an opportunity to directly serve an active community that is very proactive about seeking ways to increase their quality of life,” said Dr. Kristin Comella, USRM’s Chief Science Officer. “We look forward to serving this vibrant community by offering holistic stem cell therapy for neurological, autoimmune, orthopedic and degenerative conditions.”
Comella is not named in the new lawsuit. However, there could be an indirect connection. Oddly someone named Mary Comella is listed as the agent on the Florida State business record for Regenerative Wellness Clinic as a company, which is a defendant.
Are Mary and Kristin related? I believe Mary is her Kristin’s mother. In the past, Kristin Comella’s father Bob Comella, was also involved in some way with distribution of stem cell related materials for US Stem via his company Tampa-based distributor, Pavillion Foods Inc.
It’s difficult to get more info on Regenerative Wellness as their website now just seems to be a parked empty page.
Note that the mention in the PR of Adipocell, an SVF-like product, also suggests adipose cells may have been used by Regenerative Wellness on Mr. Pelton.
The FDA’s inaction
The FDA is part of the problem with unproven stem cell clinics in the US.
When the agency won the original court case against US Stem Cell, they released a statement that used strong words. For years FDA leadership has also published perspective papers and issued other statements suggesting they were going to take bold action on this big problem of unproven stem cell clinics.
However, they never have done much beyond the two adipose cell-related lawsuits for injunctions on both coasts.
Part of the challenge specifically on the adipose cell front is that after the successful Florida case, the agency then lost the SVF-related case here in California, what I call the Cell Surgical Network lawsuit. That case is now pending appeal by the FDA. Still, that case only directly relates to fat stem cells or SVF.
In the meantime, the overall unproven stem cell clinic numbers continue to grow in the US to around 2,000.
Hundreds of these clinics and supplier firms making unapproved drugs have nothing to do with adipose cells or SVF. What this means is that FDA oversight of them isn’t dependent on the outcome of the Cell Surgical Network lawsuit appeal.
People are getting hurt and more will be injured
In other words, the FDA could and should take strong action on hundreds of clinics and more suppliers too. Even so, the FDA continues to do almost nothing. One or a few warning letters a year in an industry with 2,000 clinics is almost meaningless. The results of FDA inaction can be devastating for patients and it’s bad for the overall stem cell field in my view.
In another Florida case related to a firm called MD Stem Cells, patients have reported vision loss after unproven bone marrow cell injections into their eyes. The FDA has been aware of this situation for perhaps a decade but to my knowledge has also done nothing about it. MD Stem Cells disputes that their cell injections caused patient injuries.
Circling back to US Stem Cell Clinic, I wonder if the FDA will try to do something if the firm did violate the injunction in this case?