A Texas firm called INCELL Corporation has received an FDA warning letter about an amniotic product it manufactures. The letter was addressed to the firm’s founder and leader Dr. Mary Pat Moyer. The letter is somewhat unusual as Dr. Moyer is the Chief Science Officer of INCELL, and is an academic scientist with over 250 publications and is an elected member of the National Academy of Engineering.
FDA warning letters to INCELL and XoBiologix
I reached out to Dr. Moyer to ask her some questions about the warning letter. I’ve included the Q&A interview below.
In summary, for background the FDA warning to her firm stated that the product in question was a drug, mentioned adulteration and misbranding of the drug, and noted CGMP issues. The letter had redacted the product name.
Dr. Moyer has indicated that the warning letter to INCELL relates to the MaviX™ product marketed by another firm called XoBiologix. This is notable in part because XoBiologix also got a warning letter related to MaviX™. The XoBiologix warning letter referenced another warning letter by number, which is the one that went to INCELL, pertaining to noted CGMP issues as related to manufacturing a drug.
Here’s our interview. I may have some additional thoughts to share on this letter in a future post.
Interview with INCELL Corporation leader Mary Pat Moyer
- What is INCELL’s overall take on the warning letter?
MPM. As INCELL’s CEO and Chief Science Officer, in my opinion, the Warning Letters to INCELL and XOBiologix are an inappropriate use of FDA power and resources and an attack on two small businesses providing clinical products important for helping people, and for which there have been no reported patient safety concerns or adverse events related to product use.
Although misstated by FDA, INCELL is not a drug manufacturer and the company maintains quality standards appropriate for development, manufacturing and testing of its own products and those made for its clients.
- The letter mentioned an amniotic product or products but it looks like there is redaction there. Can you tell us the name of the product(s) in question?
MPM. INCELL is a contract manufacturer for MaviX™ an XoBiologix LLC product composed of amniotic fluid as a flowable allograft with a formulated cryostorage colloidal medium.
- Do you disagree with the FDA that the amniotic fluid product(s) are a drug? If so, why?
MPM. Of course I disagree. I have been working as a biological laboratory scientist since I was 17 years old which means that 2025 marks 57 years of experience.
Amniotic fluid is the protective liquid contained within the amniotic sac of a pregnant woman. It surrounds and cushions the developing fetus, providing a safe environment for growth. While it plays a crucial role in fetal development, it is not used as a drug. There are no known medical or therapeutic applications for amniotic fluid as a drug.
- The letter also mentions “your product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or is intended to affect the structure or function of the body.” Can you give details on what specific diseases/conditions for which the product was being used in human patients?
MPM. The current Instructions for Use (IFU) statement included in the final packaged product is as follows:
Instructions for Use (IFU)
GENERAL USE
“MaviX™ is a sterile flowable, connective tissue and extracellular matrix human plasma-derived fluid allograft product. It is intended for topical regenerative repair and lubricating supplement to heal wounds. It is directly applied at the lesion site. It provides structure and supplies key regenerative building blocks and molecules to improve tissue repair.”
- Was your product being sold to clinics, which then marketed it to and used it in patients without FDA approval? If so, were you aware the clinics were doing that?
MPM. It is not our product. XOBiologix distributes and sells products under appropriate quality and clinical use protocols and guidances.
- The FDA noted cGMP violations, which sound concerning. Are you working to remedy those issues?
MPM. INCELL follows cGMP guidances for its manufactured and sterile fill formulated products from raw materials to the final packaging. INCELL has been manufacturing such products since 1993 and there has never been a sterile fill product failure over these 32 years and tens of thousands of product units.
The FDA cGMP violations statements were false and overreaching in imposing certain expectations and needs for DRUG product manufacturing, compliance and testing for a product that we believe is not a drug product, and for which appropriate cGMP processing, manufacturing, and testing were done prior to products being released according to a Certificate of Analysis for product lot specifications.
- I noted INCELL statements about working toward an ALS therapy. Can you tell me more about that? Is it a biologics therapy? Does it relate to the FDA warning letter or the product in question? I don’t see a Clinicaltrials.gov listing for your ALS trial. Why is that?
MPM. The ALS studies are not related to the 483 except for FDA potentially hurting our reputation.
The first two separate ALS studies were single-patient INDs that each had FDA and IRB approvals. They are not appropriate for clinical trials.gov but are foundational for safety and potential efficacy to pursue follow-on studies in more ALS patients.
The treatments are a combination cGMP manufactured cell therapy, “ALS-PACT™”, a personalized additive cell therapy (PACT) of INCELL’s allogeneic stem/stromal cells and autologous patient PBMC-derived Treg cells, both bio-manufactured by INCELL, cultured, characterized, and cryostored as cell therapy lots prior to use. The first patient, MDA, was treated for 14 months, is currently at 6 months post-treatment monitoring, and has shown persistent maintenance of functions indicating that re-acquisition of capabilities, increased strength, decreased pain, and decreased inflammation, have persisted after the treatment was stopped, and neuromuscular junctions have stayed functional. The second patient is just completing his treatments over 8 months and will be followed up. No adverse events or safety concerns were observed with either patient, who each received multiple treatments.
INCELL has been providing all the support to date for the patients, products, equipment, testing and monitoring materials, and clinical studies. It has been a very expensive undertaking. INCELL has been working with the Foundation for Cell Gene and Tissue Innovations (www.fcgti.org) to get support for clinical studies and submitting new grants for larger numbers of patients. The site shows supportive data including videos, particularly with the first patient.
The treated ALS patients have shown significant clinical improvements without disease progression. This is the first time any therapy has successfully improved ALS patient outcomes, so we are expanding plans to treat more ALS patients, as well as those with other neurodegenerative disorders, under INDs and eventually to provide approved, clinical cell therapy products. We hope to be awarded government and private grants to support ALS clinical studies to hopefully help bring life-changing improvements and relief to ALS patients, their caregivers and families. Recent cut-offs of federal funds by the new administration may hurt these and many other patients with acute and chronic diseases.
It is my life’s work and mission to bring beneficial therapies to the clinic and to support next generations of scientists and STEM innovators. However, as a researcher and small business leader, I think we should not be quixotic, but we need to be vigilant and have courage and commitment. The sad truth is that the goals to bring new products to the clinic are seriously compromised by overzealous FDA regulators, and by FDA’s greater support for larger, profit-only driven pharma companies. This impacts not only the lives of ALS patients, but other rare disease sufferers, and so many people who are at risk and in need.
There have been many FDA warning letters to amniotic/umbilical related manufacturers providing stem cells, exosomes, etc. I’ve see a lot of the letters follow the “you didn’t follow cGMP” and “this is a drug” theme.
The question is, should cGMP be the standard for these companies? Or is there something else they should follow?
As long as the product isn’t manipulated very much, wouldn’t it be more of a transplant than a manufactured drug?
For instance Neobiosis had a cGMP FDA letter. But Dr. Ian White is a pretty dang experienced scientists from what I gather…. I’m sure he knows all about clean manufacturing protocols, but did the goalpost get moved on him? Something doesn’t seem to add up but I’m not experienced enough to know.
@EV, In my view, cGMP standards are the right way to go for perinatal products for most applications out there being marketed and I see them as drugs. Others see it differently though. It’s also possible the FDA position could change in coming years to be less strict.
In general, perinatal products can have risks, especially when infused but also when put on open wounds. Probably the biggest risk is infection. For instance, perinatal material also has a higher risk of already being contaminated from the start.
One challenge in the perinatal biologics space is if products are sterilized in some way during the production process such as by heat or irradiation, then that may destroy some of the regenerative potential.
Thank you!
That’s a wise take, the safer the better especially given the industry’s history. But if they’re classified as “drugs”, doesn’t that raise the bar on what they’d have to do before going to market? Clinical trials, 100s of millions of dollars, etc.?
If my thought is right, then seemingly the only ones capable capital wise are Pfizer, J&J, etc. and there’s potential that perinatal products would cannibalize some of their pharmaceuticals that make them billions of dollars. Business (shareholder) wise, that’s a huge no-no.
Getting into the conspiracy realm here, but if what I said above is correct, it’s quite the quagmire that will likely result in a stalemate.
In my mind, something needs to give… there are too many people like myself with health problems that simply have no solutions in the USA. Maybe federal laboratories do an operation lightspeed, all the perinatal clinics pool up, or the feds create new regulatory requirements to keep up with the new technology in a way that doesn’t harm patients but also doesn’t hold them back via pharmaceutical oligarchy.
I could be way off on my interpretation above, just throwing thoughts out.
I’ve been dying to hear the other side of this. Thank you for the article and everything you do.