The recent news that Texas A&M University has inked a full-blown deal with the direct-to-consumer stem cell clinic firm Celltex struck me as an unusual development.
Recently we’ve seen more universities exploring the use of stem cells outside of the traditional FDA clinical trial process that is fundamentally based on an investigational new drug application (IND). Some institutions apparently have even potentially started teaming up with clinics for patient treatments muddying the waters out there. However, in the case of Celltex and Texas A&M my guess would be that they are going to work on their joint project within the FDA trial system. We’ll see what more we learn over time.
A reminder is in order here that a half-dozen or so years ago Celltex got an FDA warning letter that led the firm to start doing stem cell transplants across the border in Mexico. A main issue at hand at that point was the use of an adipose stem cell product that the FDA called a biological drug, but that lacked full FDA pre-market approval. With a new Texas state law that on some levels is friendly to stem cell firms that seem to operate outside the traditional FDA clinical trial framework, I’ve been wondering: might Celltex aim to bring more of its efforts back into its home state? This news regarding working with Texas A&M suggests a potential affirmative answer.
What exactly is this new deal between Texas A&M and Celltex?
It appears to be focused on testing the idea that mesenchymal stem cells (MSC) or more specifically their exosomes (little subcellular packages by which cells can share resources or influence each other’s behavior) could help with Alzheimer’s Disease (AD). Could exosomes reduce inflammation in the diseased brain in a meaningful, safe way? If so, would that help AD? The Texas A&M researchers have some notable initial data on these exosomes in an animal model, but I’m not clear on how directly relevant it is to the proposed work as I need to do more reading.
There aren’t a lot of specific details of the agreement between the Texas A&M Institute for Regenerative Medicine and Celltex in the press release either. An article by Todd Ackerman in the Houston Chronicle provides some more answers. In the deal, Texas A&M gets funding from the company for the use of the technology:
“Celltex will pay Texas A&M $2.4 million to acquire the technology and ultimately bring it to market.”
Celltex gets intellectual property and potentially boosted credibility from Texas A&M, which could be worth way more than $2.4 million to the company. Again, the firm ran into FDA issues a half-dozen or so years ago, but Ackerman’s piece quotes the company saying that things are different now:
“The company is currently compliant with the FDA, said David Eller, Celltex’s CEO.”
Ackerman’s article doesn’t provide context for objectively evaluating Celltex’s statement of compliance. We need to learn more about what this means. The FDA decides what’s compliant and what isn’t, and we don’t know if FDA recently told Celltex that they are compliant and for what specifically.
Moving forward, will this team effort with Texas A&M need an IND to be compliant prior to going into human studies? It seems so from my perspective and I’d imagine the Texas A&M researchers will work with the FDA to build an IND application. Why would an IND most likely be needed here?
If there is infusion of adipose MSCs into patients for AD, that sounds like it would potentially involve both more than minimal manipulation and non-homologous use designations coming into play, both possible regulatory triggers for requiring an IND and pre-market approval by the FDA. However, it’s hard to know without more details.
What if it’s just the exosomes? Even though stem cells themselves may not be used here ultimately in patients in a trial if the work gets to that point, my understanding is that exosomes would be considered a biological drug. In fact, to make adipose MSC exosomes for infusion one would need to first isolate fat stem cells (which the FDA has said makes the cells a drug) and then isolate exosomes from them. To me that sounds like a lot of production steps if one would claim minimal manipulation. If the MSCs are grown in a lab prior to isolation of exosomes that could also contribute to making the product a drug. For these reasons, the team may be planning an IND for this joint effort as they approach the point of a future Phase I trial.
More broadly, I wondered about a possible Celltex IND a few years back in my 2015 yearly stem cell predictions, but that prediction was specifically related to their own MSC transplants directly to consumers. On that front, I don’t know if they have or plan to get an IND, or if they hope to resume those particular clinical operations within Texas rather than just Mexico, but from the Chronicle again, Celltex does seem to be aiming to get more clinical work going in Texas:
“Under a new state law that sanctions experimental stem cell therapy in Texas, Celltex hopes to again begin providing its stem cells to doctors and hospitals in the state, said Eller. Celltex, he said, is waiting on rules being drawn up by the Texas Health and Human Services Commission as part of the law, passed by the 2017 Legislature.”
If Celltex resumes MSC injections in Texas without an IND (to be clear this would likely be independent of the work with Texas A&M, and again for all I know Celltex could have an IND for their MSCs), could there end up being an interesting collision of state and federal authorities as this develops? This is going to be an important story to follow on many levels.