September 18, 2020

The Niche

Knoepfler lab stem cell blog

Historic spring storm of FDA letters to stem cell clinic industry

FDA letter, FDA warning letter, FDA untitled letterThe 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.”

April 1, 2020 letter to Dale Carrison D.O., Dynamic Stem Cell Therapy.The letter refers to panacea-like marketing in my view:

“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).”

April 10, 2020 letter to Kimera Labs (exosome supplier; Douglas Spiel, M.D. and Duncan Ross, Ph.D.). Note that Spiel also got a separate letter on the same date (below). Also, here’s a post I did on this Kimera situation, which involved 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.

April 10, 2020 letter to Douglas Spiel, M.D. From the agency letter:

“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.”

Henry N. Small, M.D.
Henry N. Small, M.D.

April 28, 2020 letter to Valeo MD  (Giovanni Ramundo, M.D.) From the agency:

“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.”

May 11, 2020 letter to Sparrow Health & Performance, LLC (CEO Rebecca Rogers) From the letter:

“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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