The FDA has stem cell clinics squarely on its radar screen now and it’s pulling the trigger with many letters going out to this problematic industry. In the past, sometimes years went by with no letters at all or one letter in total to stem cell clinics so this marks a major shift.
Background on lead-up to wave of FDA activity
I count 7 letters in a less than two-month span from mid-March to now, which may be the most in history in the overall stem cell ecosystem.
I suspect this has a lot to do with the upcoming November end to the 3-year FDA grace period for stem cell clinic firms and other related entities like suppliers. The suppliers of biologics in this space have become particularly problematic. Another harmful trend is clinics making claims about COVID-19.
Just 6 months from now in November the agency may use all these untitled and warning letters as a foundation to actually take more robust action against some of these firms if the companies don’t make big changes. You may also find this new MedPage Today article by Kristina Fiore on stem cell clinics and COVID-19 useful.
This post is focused on the recent letters to stem cell clinics and regenerative medicine firms including those often troubling (in my view) suppliers. I’ve included the “money” (key) quotes from the FDA letters below each entry. Note that Liveyon received a warning letter in December 2019 as well. I would consider that part of this trend, just before it really got going faster.
I tried to find any helpful YouTube videos on FDA letters, but nothing jumped out at me. I did this valuable talk from the Alliance for Regenerative Medicine (ARM) on FDA trial guidance related to COVID-19.
The flood of FDA letters
March 16, 2020 letter to Invitrx, leader Habib Torfi. This firm had been involved in an unproven stem cell infusion received by William Shatner of Captain Kirk fame. I did a post on it here.This was a warning letter so more serious than some of the other and the FDA said the products are drugs. A key excerpt:
“During an inspection of your firm Invitrx Therapeutics, Inc., located at 20503 Crescent Bay Drive, Lake Forest, CA 92630, conducted between March 25, 2019 and April 3, 2019, the Food and Drug Administration (FDA) documented that your firm processes products for allogeneic use, including the following products (referred to collectively in this letter as “your products”): human umbilical cord blood, or umbilical cord derived products, Invitra CBSCTM and Invitra WJTM (Cellular and Acellular); amniotic fluid derived product Invitra AFTM; and amniotic membrane derived product Invitra ATTM.”
“You and your firm market cellular products derived from adipose tissue and human umbilical cord (i.e. Wharton’s Jelly) as “stem cell therapy” and/or “regenerative medicine treatments.” You market your products for “cardiopulmonary conditions,” “degenerative eye diseases,” “neurological disorders,” “autoimmune diseases,” and “metabolic disorders.” Among other diseases or conditions, you also market your products for the treatment of congestive heart failure, cardiomyopathy, chronic obstructive pulmonary disease, macular degeneration, retinal micro-hemorrhage, Alzheimer’s disease, spinal cord injury, “Stroke Damage,” lupus, rheumatoid arthritis, multiple sclerosis, “cognitive impairment,” Crohn’s disease, inflammatory bowel disease, diabetes, cirrhosis, Graves’ disease, myasthenia gravis, liver disease, fibromyalgia, hypertension, and Lyme disease. Your cellular product derived from adipose tissue is administered intravenously. You also recently began marketing your cellular products for treatment or prevention of Coronavirus Disease 2019 (COVID-19).”
“Kimera Labs markets exosome products to treat numerous diseases or conditions, including some that are serious or life-threatening. These products are administered by various routes of administration, including intravenously. Kimera Labs also supplies its products to health care providers such as Dr. Spiel, who is both a Clinical Consultant for Kimera Labs and President of Regenerative Solutions of New Jersey. Regenerative Solutions of New Jersey markets these products to mitigate, prevent, treat, or cure Coronavirus Disease 2019 (COVID-19).”
Dr. Doug Spiel of Regenerative Solutions of New Jersey, who used to also be on the team at Kimera. Screenshot from video.
“You and your firm market exosome products from Kimera Labs, Inc. for numerous diseases or conditions, including some that are serious or life-threatening. These products are administered by various routes of administration, including intravenously. Most recently, you market these exosome products on your Facebook page to mitigate, prevent, treat, or cure Coronavirus Disease 2019 (COVID-19).”
April 27, 2020 letter to Houston Stem Cell (Henry N. Small, M.D.) This is a cord blood stem cell clinic, making some extraordinary claims about a wide variety of very serious diseases that can be treated. From the FDA:
“On your website, you market an umbilical cord blood derived cellular product, which you refer to as “cord blood stem cells” and “stem cell therapy,” for numerous diseases or conditions, such as Parkinson’s disease, Alzheimer’s disease, lupus, and fibromyalgia.”
“You and your firm market “stem cell therapy” derived from adipose tissue “to treat many neurological, inflammatory and degenerative illnesses.” According to your website, your adipose-derived cellular product (product) is administered intravenously.”
“On your website and Facebook page, you and your firm offer cellular products derived from adipose (fat) tissue as “stem cell therapy” to treat the following diseases or conditions: “arthritis, asthma, autoimmune, cardiomyopathy, CIDP, COPD, Crohn’s disease, degenerative spine and disc disease, Lichen Sclerosis, Lupus, Multiple Sclerosis, Muscular Dystrophy, Myasthenia Gravis, Neuropathy, Orthopedics, Parkinson’s disease, Peyronie[’]s disease, relapsing polychondritis, Scleroderma, stroke recovery and urological conditions.” These products are to be administered by various routes of administration, including intravenously. Most recently, you offer your adipose tissue derived cellular products to mitigate, prevent, treat, or cure COVID-19.”
Take-home on the FDA spring deluge
This torrent of letters means that stem cell clinics and related firms are increasingly on notice that they have the FDA’s attention. More action may be coming soon for them.
I also expect more letters from the FDA in the next 8 weeks. The days of flying under the radar aren’t entirely over for some firms with hundreds of clinics out there, but it’s gotten much harder and riskier to count on that. Also, marketing unproven regenerative offerings for COVID-19 is a terrible idea, is bad for patients, and rightly puts your firm more squarely in the sights of the FDA too.
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7 thoughts on “Historic spring storm of FDA letters to stem cell clinic industry”
Joanne Halbrecht
Manufacturers, practitioners and consumers need to be aware that the FDA has NOT instituted a “grace period” for compliance. ALL HCT/P’s need to comply with the FDA Guidance NOW. (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimal). The FDA has given manufacturers time to determine if they need to submit an IND and DOES NOT ALLOW FOR MARKETING OR USE of any HCT/P’s that are not compliant. During this “discretionary period” the FDA is sending warning letters to those who use and market “higher risk” products such as allogeneic, IV-administered and those intended for non-homologous use. Prosecution will follow.
This from the FDA document:
“To give manufacturers time to determine if they need to submit an IND or marketing
application in light of this guidance and, if such an application is needed, to prepare the
IND or marketing application, for the first 36 months following issuance of this guidance
FDA intends to focus enforcement actions on products with higher risk, taking into
account factors such as whether the product is for non-autologous (allogeneic) use and
the route and site of administration. For example, actions related to products with routes
of administration associated with a higher risk (e.g., those administered by intravenous
injection or infusion, aerosol inhalation, intraocular injection, or injection or infusion into
the central nervous system) will be prioritized over those associated with a lower risk
(e.g., those administered by intradermal, subcutaneous, or intra-articular injection).
HCT/Ps that are intended for non-homologous use, particularly those intended to be used
for the prevention or treatment of serious and/or life-threatening diseases and conditions,
are also more likely to raise significant safety concerns than HCT/Ps intended for
homologous use because there is less basis on which to predict the product’s behavior in
the recipient, and use of these unapproved products may cause users to delay or
discontinue medical treatments that have been found safe and effective through the New
Drug Application or BLA approval processes.”
Yeah, if you recall that the agencies have a bunch of problems that you need to pay attention to now and know the fact that they do not have power in court in these cases. One could say that they are not doing that. But this is actually interesting. It is clear that hardly anyone will go to court with this. There are real people who have suffered from this. And all this is due to poor-quality or speculative behavior of individuals or companies. So it would be better for the guys to concentrate and take a class action lawsuit. Thanks for the article, it really is very interesting.
Its about time. I really feel like many of these clinics began offering treatments/cures for COVID-19 and the FDA has been pretty clear that’s a red line. Hopefully more action will follow soon. Can they take on all 1000+? No. But just like police don’t nab every last speeder, its the same thing here. Will we ever stamp out every last criminal? Nope. But we still set examples and have laws to protect us. I expect this to be the same.
Id be willing to bet that the FDA extends the moratorium at least another year. After speaking with several CEOs in the allograft space and one with a clinic offshore. Most mentioned speaking directly with FDA and the FDA wanting to work with them, not against. Probably doesn’t fit your narrative but especially after COVID, the FDA has bigger issues that are on their mind.
It doesn’t seem like the FDA’s letter has had much of an effect on Dr. Small lol – https://www.henrysmallmd.com/services/stem-cell-therapy Also, I wouldn’t consider 6 letters a “storm”. Well, for the FDA it might be. 6 down, 1,243 to go! Also, the FDA doesn’t have the manpower to take all these manufacturers and clinics to court. I agree that it will be interesting to see what they do this coming fall. I suspect they’ve got bigger fish to fry with COVID, at least right now.
@Bill,
7 letters in <2 months is a lot, especially compared to previous periods and as you go back a few years when some entire years there was no activity at all.
I agree the scope of the problem is huge and the agency has tons of other things to focus on, but I think once November comes along we'll see the agency do some more assertive things, in part based on the foundation of these letters. We'll see if I'm too hopeful.
I feel like such a sucker. I bought the dream of stem cells hook line and sinker. I used to think you were way out there and trying to stop something that you and the FDA should stay out of. $10,000 dollars later, and my stored stem cells now held up under a court order at US Stem Cell, all I have to show for it is feeling 100% worse after my treatment (the one where the cells came from my stored cells at US Stem Cell). After my first shot – you know, taking FAT our of my stomach and shooting it in my blood system (seemed like a good idea at the time) I hurried to have the second shot two months later. Since then I have felt worse and my stem cell doc, who was my rheumatologist (note that he “was”) would not talk to me and pushed me off on his PA. He walked right by me in the hall as if he had didn’t know me – you know, the guy who gave him 10K and was only his second stem cell case. I would never have believed it from this guy. I honestly thought he was trying to help me, and think he was at the time. But now, I’m not so sure. If he was, he should have tried to help me when I suddenly got worse (immediately after getting the second shot). He stopped seeing me, so I stopped seeing him and found a new doctor.
So I am writing to the FDA myself and telling them the details of my story so they know not to leave him out of their letter writing campaign; he makes all of the claims these other people do. I can’t get in to see him, but maybe this way he will hear from me and realize that real people are at the end of the stem cell needle. All I have to say to him is “Do no harm.”
Thanks for your articles and for letting me know about this new revelation. I would hate to be left out of the letter writing campaign.
The FDA has stem cell clinics squarely on its radar screen now and it’s pulling the trigger with many letters going out to this problematic industry. In the past, sometimes years went by with no letters at all or one letter in total to stem cell clinics so this marks a major shift.
Manufacturers, practitioners and consumers need to be aware that the FDA has NOT instituted a “grace period” for compliance. ALL HCT/P’s need to comply with the FDA Guidance NOW. (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimal). The FDA has given manufacturers time to determine if they need to submit an IND and DOES NOT ALLOW FOR MARKETING OR USE of any HCT/P’s that are not compliant. During this “discretionary period” the FDA is sending warning letters to those who use and market “higher risk” products such as allogeneic, IV-administered and those intended for non-homologous use. Prosecution will follow.
This from the FDA document:
“To give manufacturers time to determine if they need to submit an IND or marketing
application in light of this guidance and, if such an application is needed, to prepare the
IND or marketing application, for the first 36 months following issuance of this guidance
FDA intends to focus enforcement actions on products with higher risk, taking into
account factors such as whether the product is for non-autologous (allogeneic) use and
the route and site of administration. For example, actions related to products with routes
of administration associated with a higher risk (e.g., those administered by intravenous
injection or infusion, aerosol inhalation, intraocular injection, or injection or infusion into
the central nervous system) will be prioritized over those associated with a lower risk
(e.g., those administered by intradermal, subcutaneous, or intra-articular injection).
HCT/Ps that are intended for non-homologous use, particularly those intended to be used
for the prevention or treatment of serious and/or life-threatening diseases and conditions,
are also more likely to raise significant safety concerns than HCT/Ps intended for
homologous use because there is less basis on which to predict the product’s behavior in
the recipient, and use of these unapproved products may cause users to delay or
discontinue medical treatments that have been found safe and effective through the New
Drug Application or BLA approval processes.”
Yeah, if you recall that the agencies have a bunch of problems that you need to pay attention to now and know the fact that they do not have power in court in these cases. One could say that they are not doing that. But this is actually interesting. It is clear that hardly anyone will go to court with this. There are real people who have suffered from this. And all this is due to poor-quality or speculative behavior of individuals or companies. So it would be better for the guys to concentrate and take a class action lawsuit. Thanks for the article, it really is very interesting.
Its about time. I really feel like many of these clinics began offering treatments/cures for COVID-19 and the FDA has been pretty clear that’s a red line. Hopefully more action will follow soon. Can they take on all 1000+? No. But just like police don’t nab every last speeder, its the same thing here. Will we ever stamp out every last criminal? Nope. But we still set examples and have laws to protect us. I expect this to be the same.
Id be willing to bet that the FDA extends the moratorium at least another year. After speaking with several CEOs in the allograft space and one with a clinic offshore. Most mentioned speaking directly with FDA and the FDA wanting to work with them, not against. Probably doesn’t fit your narrative but especially after COVID, the FDA has bigger issues that are on their mind.
It doesn’t seem like the FDA’s letter has had much of an effect on Dr. Small lol – https://www.henrysmallmd.com/services/stem-cell-therapy Also, I wouldn’t consider 6 letters a “storm”. Well, for the FDA it might be. 6 down, 1,243 to go! Also, the FDA doesn’t have the manpower to take all these manufacturers and clinics to court. I agree that it will be interesting to see what they do this coming fall. I suspect they’ve got bigger fish to fry with COVID, at least right now.
@Bill,
7 letters in <2 months is a lot, especially compared to previous periods and as you go back a few years when some entire years there was no activity at all.
I agree the scope of the problem is huge and the agency has tons of other things to focus on, but I think once November comes along we'll see the agency do some more assertive things, in part based on the foundation of these letters. We'll see if I'm too hopeful.
Dr. Knopefler,
I feel like such a sucker. I bought the dream of stem cells hook line and sinker. I used to think you were way out there and trying to stop something that you and the FDA should stay out of. $10,000 dollars later, and my stored stem cells now held up under a court order at US Stem Cell, all I have to show for it is feeling 100% worse after my treatment (the one where the cells came from my stored cells at US Stem Cell). After my first shot – you know, taking FAT our of my stomach and shooting it in my blood system (seemed like a good idea at the time) I hurried to have the second shot two months later. Since then I have felt worse and my stem cell doc, who was my rheumatologist (note that he “was”) would not talk to me and pushed me off on his PA. He walked right by me in the hall as if he had didn’t know me – you know, the guy who gave him 10K and was only his second stem cell case. I would never have believed it from this guy. I honestly thought he was trying to help me, and think he was at the time. But now, I’m not so sure. If he was, he should have tried to help me when I suddenly got worse (immediately after getting the second shot). He stopped seeing me, so I stopped seeing him and found a new doctor.
So I am writing to the FDA myself and telling them the details of my story so they know not to leave him out of their letter writing campaign; he makes all of the claims these other people do. I can’t get in to see him, but maybe this way he will hear from me and realize that real people are at the end of the stem cell needle. All I have to say to him is “Do no harm.”
Thanks for your articles and for letting me know about this new revelation. I would hate to be left out of the letter writing campaign.
Barry