Placental biologics firm MiMedx and exosome company Kimera Labs both recently received FDA warning letters.
The letter to MiMedx was related to its placental biologics products and procedures. The new warning to Kimera Labs was about its exosome products and an amniotic product.
Let’s compare these letters starting with the one to MiMedX.
MiMedx warning letter
The FDA says in the letter that MiMedx’s product Axiofill is both a biologic and an unapproved drug. MiMedx disputes that and says the FDA hasn’t been consistent in its oversight of this arena.
Kristina Fiore over at MedPage Today has good coverage of the new MiMedx warning: Company Warned Over Human Placenta Product.
For further background, MiMedx got the new FDA warning about 10 years after receiving an untitled letter from the agency related to a ‘stem cell magnet‘ product. That’s an interesting, old story unto itself.
Fiore also covers some other past issues for this firm:
“The company has faced its share of controversy, including charges involving its marketing and accounting practices, and allegations that it shipped more product than had been ordered and booked that as sales.
Then, in 2020, MiMedx Group agreed to pay $6.5 million to resolve allegations that it knowingly submitted false commercial pricing disclosures to the Department of Veterans Affairs, enabling the company to charge inflated prices for its human tissue graft products.”
The letter to MiMedx also noted CGMP deviations.
Kimera Labs warning letter
The warning letter to Kimera Labs is its second in a few years. Yet within the same period the firm got a cleared IND too for studying exosomes for COVID. Feels a bit like a rollercoaster of news to me.
The new letter states:
“The FDA documented that you manufacture exosome products, XoGlo® and XoGlo®Pro, and an amniotic fluid product, Amnio2X®, for allogeneic use (collectively, “your products”)…Therefore, your products are drugs”
The letter goes on:
“Kimera Labs has an IND in effect for XoGlo®Pro (IND 26535) as of May 12, 2023. However, pursuant to 21 CFR 312.7(b), a sponsor or investigator shall not commercially distribute or test market an investigational new drug. Based on this information, your actions have violated the FD&C Act and Section 351(a) of the PHS Act.”
The Kimera warning letter is dated September 1, 2023. Why is it just being released now?
Overall, in the new warning letters to both firms, the FDA notes apparent unapproved biological drug marketing and CGMP deviations.
This fits the pattern of various types of letters from the agency to many firms in the perinatal biologics space in the last three years.
FDA letters in general don’t seem to work
More broadly, I believe the FDA’s main strategy of sending various types of letters to unproven cell therapy clinics and manufacturers isn’t working.
Whether it’s fat cells, birth-related cells, or other materials, the clinics and manufacturers just keep on going whether they get letters or not.
The agency needs a new approach that is broad, nimble, and leads to concrete results.
As I’ve now said many times, fines are perhaps the best option. They potentially could be issued to dozens or even hundreds of firms without prior inspections. Is there some legal or practical obstacle to fines?
The FDA recently said it has issued 28 warning letters, 40 untitled letters, and more than 600 unspecified letters in the unproven, direct to consumer, cell biologics arena in the last 5 or so years.
What percent of these were concretely effective?
NYT deep dive on Bryan Johnson Longevity movement
The Meme King of Longevity Now Wants to Sell You Olive Oil, NYT. This is a refreshingly thorough look at the longevity efforts of Bryan Johnson. It has some interesting background:
In 2007, he founded his own payment processing company, Braintree, which acquired the startup Venmo and, in 2013, was itself acquired by eBay for $800 million.”
His anti-aging efforts are a newer direction.
The NYT piece discusses how he has a massive following who seem to want to be like him.
“In conversations about Blueprint, it’s hard to avoid the word cult. Mr. Johnson himself likes to joke: “Is this some sick and twisted cult trying to get me to go to bed on time?”
Jeff Tang, who recently started a Blueprint-based meal prep company in the San Francisco area, said a lot of businesses “feel like cults at the beginning,” citing WeWork as an example.”
They follow his lead on some longevity efforts. Some of these folks even wear “don’t die” t-shirts too.
Other recommended reads
- Stem cell-based therapy deemed safe in Phase 2 study, ALS News Today. Here’s the research article in Cell Transplantation: “Safety and Clinical Effects of a Muse Cell-Based Product in Patients With Amyotrophic Lateral Sclerosis: Results of a Phase 2 Clinical Trial,” No clinically significant improvement was reported. The trial used something called CL2020, a MUSE cell product. I’m not sure MUSE cells even exist.
- Depletion of SAM leading to loss of heterochromatin drives muscle stem cell ageing, Nature Metabolism. Definitely worth a read.
- New Opportunities for Human Stem Cells in Research and Clinical Applications. This seminar hosted by STAT News should be interesting. The speaker is Ilyas Singeç, M.D., Ph.D. CSO of FUJIFILM Cellular Dynamics.
- Finally, for fun, check out this dumb stem cell headlines piece from 2013. Although that was 11 years ago, sometimes the media headlines today in the regenerative space are just as bad.
Dear Dr. Knoepfler,
I thought that this was an open forum, and participants could post their thoughts and opinions. What Jake is posting is in opposition to your continued denial of the potential benefit of uMSCs and seemly focus on the potential negative aspects exemplified by isolated malicious clinics or individuals.
It is obvious that the broadcast knowledge of uMSCs, and applications in the regenerative translational medicine theater is limited, but the awareness is growing every year.
If Jake has information to share it should be allowed. I have posted my thoughts and experiences with a positive light of the use of uMSCs.
Here is something to consider:
https://www.mesoblast.com/product-candidates/product-candidates-overview
Bryan Johnson is using now using exosomes on his face and scalp.
https://youtu.be/ic5mjSmrWqk?si=vCkUJCtndQRBtSLi
This is what he uses https://anteage.com/products/exosome-solution
Also Bryan Johnson is now using bone marrow mesenchymal stem cells, do you think you could do an article on this?
I’m not a scientist or an investor, I’m actually unemployed right now, I’m 35, I just have a huge interest in science and technology, I think about the future a lot and how technology will shape the future. I’m into futurism. I’m basically obsessed with the future. I read science fiction books, I like hard science fiction.
I first learned about mesenchymal stem cells thanks to Joe Rogan when he interviewed Neil Riordan back in 2018. I’ve been obsessed with MSCs ever since!!!! I read Neil Riordan’s book and it blew my mind!!!!
Apparently Neil Riordan is curing people of congestive heart failure using umbilical cord MSCs, and honestly I think he’s telling the truth.
Do you understand what a huge breakthrough this is? If umbilical cord MSCs really can cure heart failure then that is a huge breakthrough!
You saw my link to the University of Miami clinical trial right, https://classic.clinicaltrials.gov/ct2/show/NCT06145035?term=Mesenchymal+Miami&sort=nwst&draw=2&rank=1 I’ll be keeping an eye on that one.
Back in 2010 I read Ray Kurzweil’s book The Singularity is Near (I think the technological singularity will occur by 2050) and it completely opened my eyes, it changed the way I see the world. So I’m always on the lookout for the next big breakthrough.
To me, umbilical cord MSCs is the next big breakthrough. Exosomes too.
In fact exosomes might even replace cell therapy altogether.
I would love to hear an update on the CuRe trial were they’re trying to cure a spina bifida using placenta derived mesenchymal stem cells?
Also, do you know if they have grown a human embryo for longer than 14 days yet? One of the researchers said he was going to see if he could grow a human embryo for 21 days, I wonder if they’ve done that yet? Designer babies are coming, it’s inevitable, we will eventually genetically engineer our children. Genetically engineered humans will exist before the end of the 21st century.
So in the future designer babies will be a full-blown reality, we will be able to give our children blonde hair and blue eyes, high intelligence, and good health. Seriously genetic engineering is the future!!!
And then of course the artificial womb is fast becoming a reality as well.
Also they can now take a skin cell from a mouse and turn it into sperm or an egg. Here’s what they did, they took skin cells from a male mouse and turned it into eggs, and vice versa they can create sperm from a female mouse. They have literally created mice pups this way. They are now trying to do this with humans, it’s called in vitro gametogenesis.
So in the future you’ll be able to create eggs from men and sperm from women. You’ll be able to have beautiful blonde haired blue-eyed designer babies, and they’ll be grown and born from artificial wombs.
It’s funny, one of the scientists working on in vitro gametogenesis is a gay man and he has a gay lover, his goal is he wants to be able to create eggs from his gay lover so they can have biological children together. In fact there are quite a few gay scientists working on in vitro gametogenesis. So doing this two men will be able to have biological children together and vice versa two women could have biological children together.
Genetic engineering will be everywhere in the future, I’m sure of it.
p.s. oh and using full body MRI they were able to catch one woman’s lung cancer at stage 1, so it saved her life. She said she would have known about her lung cancer when she was coughing up blood and by then it would have been too late.
Thanks for sharing this….
Is Riordan claiming to cure congestive heart failure now? That’s a pretty bold claim!
To Jake,
Your enthusiasm for biomedical science and stem cell stuff is great, but anyone can claim just about anything (even without good data) and it happens all the time in the stem cell and anti-aging areas.
Jake: I did a little searching and cannot find anything about Riordan claiming to cure anything. His clinic in Panama does claim to treat multiple conditions but I didn’t even find the word “cure” on the main pages of his site in Panama (Google search). The FAQ page states:
How long will it take to see results?
Each patient is unique, and there is no guarantee that positive results will be seen or how quickly they may be observed. Some patients have reported improvements during the course of their treatment, while others have experienced improvements as long as 6 months after returning home. However, not all patients improve.
You obviously haven’t read Neil Riordan’s book that he published back in 2017 “Stem Cell Therapy a Rising Tide” in this book there is a chapter on heart failure and he tells you the results he’s witnessed using umbilical cord MSCs for heart failure.
I do think that in the end it will be proven beyond a doubt that umbilical cord MSCs and the exosomes they secrete can literally cure heart failure. Ultimately it comes down to the exosomes that are secreted by mesenchymal stem cells, the stem cells secrete exosomes and the exosomes is what tells the body to heal itself.
Jake, you keep promoting stem cell clinics in your comments so I have to either not post them or edit them per The Niche comment policy.
Also, as I’ve said before, clinic owners often write books promoting what they sell. It doesn’t mean everything in such books is scientific or medical fact. Some of it is just one person’s opinion. These aren’t like textbooks where everything has be indisputable facts.
When you buy a car do you believe everything the salesperson tells you or that the car company has said online? I don’t.
Jake, Testimonials are not science. They are very much “sus”
If Bryan Johnson posted and article that eating granite rock flakes will cure cancer, would you consider that as good information?
Science it must be repeatable, robustly tested. While MSC hold great promise, there are no approved treatment here in the US, because you can’t just inject some and get results. But that’s what these clinics and paid testimonials do.
We appreciate your excitement. But… as the flat earthers have found… (rocket) science is hard. Medical science is hard.
https://www.bbc.com/news/world-us-canada-51602655
Sadly, these unproven clinics are the flat earthers of the medical community.