Starting last year the FDA has focused much of its cell therapy oversight resources on birth-related firms, including both clinics and suppliers. The latest warnings went to RenatiLabs & Cell Genuity.
Warnings to unproven perinatal cell therapy firms
Earlier this summer the agency warned Regenative Labs. There have been quite a few letters to others in this space as well.
These warnings often flag two key general issues. First, the letters note that the amniotic or umbilical cord cell therapy products in question appear to be unapproved drugs. Then the FDA almost always lists GMP/CGMP type problems too.
What’s up with the latest warnings?
Cell Genuity
This firm, also known as Stratus Biosystems, received a warning letter for their umbilical cord and amniotic products. The June letter was addressed to Lisa Sooter, General Counsel and Co-Owner. The FDA letter calls them “CellGenuity” without a space between the words.
The agency noted in the letter that the product, AmnioAMP-WJ, is both a drug and a biological product. Some clinics and suppliers seem to think one product can only be one of these things. In fact, a product often is both. The FDA describes another of their products, AmnioAllograft, as a drug too.
The agency also noted six main types of CGMP issues as well with multiple bullet points sometimes listed under each category.
It is further noted that in a reply to the FDA, “Stratus has stopped manufacture of products until such time as the FDA inspector observations can be addressed.” But are clinics still using the products on patients?
The Cell Genuity website still says, “CellGenuity develops biologics designed to be used as a therapeutic agent. Formulated with our patented PūrAMP Process™, our products are used in a wide range of surgical and non-surgical applications.” Present tense.
RenatiLabs
The warning letter to Renati Labs went to Leonid Macheret, MD. It focuses on the firm’s umbilical cord product WJMAX.
As with Cell Genuity and now many other birth-related tissue firms like Regenative Labs, this letter notes that the product in question is an unapproved drug.
Also sparking deja vu, the letter in this case notes significant CGMP deviations as well.
Past infections in this space
In the big picture, CGMP deviations in the perinatal arena should be considered in the context of the history here. That includes the umbilical cord product firm Liveyon. In that case, dozens of people got life-threatening infections. Some ended up in the ICU.
Other infections have been noted using birth-related cell therapy products as well.
Possible exposure of clinic customers to supplier products made without solid CGMP is a real concern moving forward.
Broader FDA focus on birth-related cell therapy firms
Overall, why is the FDA focusing so much on makers of unapproved amniotic and umbilical cord drug products?
There are a couple of likely reasons.
First, these products are completely unrelated to the still pending Cell Surgical Network lawsuit, which is centered on adipose cell products and clinics. Thus, no matter how the FDA’s appeal of that case goes at The Ninth Circuit Court, the oversight actions on birth-related firms should be unaffected.
Second, it’s likely that the Liveyon disaster has made the agency consider these kinds of firms to be at a relatively high risk of exposing future clinic customers to pathogens. Also, FDA inspectors report consistently finding CGMP problems too at these manufacturers, fitting with disease transmission risk.
Looking ahead
Overall, while I still think the FDA needs to do far more on stem cell clinics and related firms like biologics producers, their focused attention on the perinatal cell therapy space could have some very positive impact.
However, we don’t want to see it just be a whack-a-mole situation. A concern is that as the FDA warns individual manufacturers and some of them stop producing these perinatal cell therapy drugs, other new firms just pop up to meet the demand. For that reason, the agency needs to go even bigger here. Expanded action could include steps against more clinics that buy these unapproved drug products. I still believe that issuing large FDA fines against large numbers of clearly non-compliant firms is the way to go for the agency more broadly in dealing with the unproven clinic industry.
Hit them in the pocketbook and they’ll pay attention.
For more background, see this explainer post: What is an FDA warning letter & how should firms respond?
Stem cell therapy give you energy to walk without walker
Based on what evidence?
“First, the letters note that the amniotic or umbilical cord cell therapy products in question appear to be unapproved drugs. Then the FDA almost always lists GMP/CGMP type problems too”. Good grief! Is there anything that the FDA does NOT consider to be a drug?
To answer your question literally (even though I don’t think you meant it that way) it seems that most blood cells and bone marrow cells haven’t been treated as drugs. Even bone marrow cells used in a non-homologous way, which seem to be drugs, have not sparked any FDA action. Unaltered fat (other than trimming and washing) is not a drug even when transferred. There are other examples.
A drug essentially is anything the FDA says it is in its’ pretzel logic sort of way. Homologous use and more than minimal manipulation are terminologies invented by the FDA following that cellular material was found to be of therapeutic benefit when utilized in an autologous sense. FDA made changes to their own Codes of Federal Regulations in 2006 to justify big government interference into the practice of medicine and garner more power to FDA AND to the industries they have conflict of interest relationships with. (Big Pharma) Unfortunately Judge Bernal did not “go big” and mention this in his decision favoring Cell Surgical Network over the FDA recently. RFK jr has at least mentioned it in his writings as well as interviews.
How can a judge make a decision on what is a drug or not? This is insane …you want another thalidomide tragedy by bozos injecting weird ill defined potions in people? Or putting exosomes on faces???
I am tired of me having to spend money and do things the “right way” while all these idiots are using weird arguments and putting people’s lives and the whole damn field
At risk
Sorry but i am furious
Thomas ichim
I have to spend significant amounts of money on trials and preclinicals while people like this sell directly to patients with no respect for safety or the law
They should all be put in jail in my opinion.
Then these guys tell me that “exosomes are legal” and “stem cells are legal”…pure insanity