What’s ReCELLebrate?
Sometimes I end up on mailing lists from companies selling biologics for which I don’t see clear FDA approval. Not all biologics need drug-level approval from the agency, but many do. All exosomes appear to require FDA approval before use.
ReCELLebrate is a regenerative firm that just sent me two marketing emails. The emails surprised me so I decided to take a look at what they are selling.
The firm offers exosomes and maybe stem cells.
Remarkably, the emails say they are giving these exosomes by IV at a booth at a meeting starting today. What does this all mean?
ReCELLebrate IV exosomes at meeting
Above you can see an image of part of one of the emails. This is striking for several reasons.
First, in my view, getting IV exosomes at a meeting is going to come with some possible risks. While the firm appears to be focusing on plant exosomes with its LONGEVEX product, my impression is that an IV procedure giving plant exosomes would likely be classified as use of a drug as is the case with animal cell exosomes.
Why is this likely? To my knowledge, the FDA still generally views exosomes as drugs. For that reason, the agency must give drug-level approval for exosome products before any clinical use. That’d be true whether in a medical clinic or a booth at a conference. As many biotechs working on various biologics will attest, drug-level approval is very difficult to get. For example, the FDA requires strong data from careful clinical trials.
As far as I know, no firm has received FDA approval to market or use exosomes, whether from plants, human cells, or other sources. So how can ReCELLebrate be offering what sounds like a probable exosome drug product this week at a meeting booth? Maybe they believe their plant exosomes are not a drug?
Dr. Jeffrey David Gross leads ReCELLebrate
What’s the leadership of this firm?
Dr. Jeff Gross leads ReCELLebrate. He describes himself as the “Stem cell whisperer” on LinkedIn.
I reached out to Gross there to try to get in touch. I wanted to start a conversation by asking about ReCELLEbrate’s exosome marketing, etc. but so far have not gotten a reply. If I do, I plan to post it.
On Reddit, someone in the subreddit on stem cells has raised potential concerns about a Dr. Jeffrey D. Gross in connection with this firm. Same Dr. Gross?
Stem cells too?
Beyond exosomes, ReCELLebrate’s website also seems to suggest marketing of stem cells, “Stem cells can be obtained from a variety of sources, including bone marrow, adipose tissue, and umbilical cord blood. At ReCELLebrate, we favor the perinatal sources, which are obtained ethically and are screened and processed in conjunction with FDA certified and compliant labs.” Are they just mentioning the stem cells they think are the best without actually selling them?
Note that more generally using biologics from FDA-certified and compliant labs doesn’t mean those drug products have FDA approval. You can see my list of FDA-approved cell and gene therapies. While the list is growing, there aren’t that many kinds of approved cell therapies.
In the big picture, how could a firm administer IV exosomes at a booth at a meeting? I wish I was there to go and chat with them.
I’m more used to getting basic swag like magnets, posters, and such at conference booths.
What stood out to me is the conference-booth setting: people are used to seeing posters or basic swag there, not something framed like an IV biologic intervention. The distinction you draw between a lab being FDA-certified or compliant and a product actually having FDA approval is also important, because that nuance often disappears in patient-facing marketing. Do you think regulators should treat “plant exosomes” messaging mainly as a product-classification problem, or as a risk-communication problem for patients who hear “natural” and infer “low risk”?