‘Captain Kirk’ regenerative clinic supplier Invitrx gets long FDA warning letter

Should we call it stem cell synchronicity for stem cell supplier firm Invitrx?

What was it about March 16?

Sometimes strange things happen in the stem cell world such as last week on March 16 I wrote that the FDA needs to do more about unproven exosomes, and then on the same day a new FDA warning letter went out to Invitrx mentioning almost as an aside an unapproved exosome product amongst many other products and issues.

No, I don’t have some secret red telephone where I can alert the FDA to do something about an urgent situation. I think some folks at the FDA read my blog, but an action like a warning letter can be in the works for months.

Update: since March 16, the goods news is that the FDA has done even more about the selling of unproven exosomes, including for COVID-19.

What’s the backstory with Invitrx?

I wrote last year about how actor William Shatner (perhaps most famous for playing Captain Kirk on Star Trek) received an unproven birth-related stem cell injection and how he had promoted it on Twitter, including mentioning the producer firm Invitrx. You can see the tweet below.

I connected with Shatner after I replied to his tweet and we had a brief, but productive exchange. I wished him well, but was worried about the unproven stem cells getting a plug.

#ad Today I received restorative stem cells from my good friend Greg DiRienzo @ProgenaCell. The stem cells were manufactured by Invitrx here in So Cal. My friend Dr Mathi Senapathi gave the cells to me intravenously. Is it possible to turn back the clock? I will let you know.

— William Shatner (@WilliamShatner) May 31, 2019

Now Invitrx is an FDA warning letter recipient. The letter is addressed to CEO Habib Torfi, pictured above.

Long laundry list of Invitrx issues

I’ve seen a lot of these warning letters over the years and this particular letter in my opinion stands out from most of the others recently. It raises many serious issues. There are 17 major observations in the letter plus some have subsections. The word “fail” or “failure” or some version of them are used 32 times in the letter.

The products mentioned in the letter include the following:

“human umbilical cord blood, or umbilical cord derived products, Invitra CBSC^TM and Invitra WJ^TM (Cellular and Acellular); amniotic fluid derived product Invitra AF^TM; and amniotic membrane derived product Invitra AT^TM.”

The FDA warning also mentions an exosome product called Invitra EXTM. The letter indicates that some offerings are likely unapproved drug products. You’d think that the FDA would be kind of upset about firms selling what seem to be unapproved drug products, but in the regenerative sphere somehow the agency is being oddly patient in most cases like this.

The big picture and looking ahead

It’s also puzzling how the FDA is sending some birth-related regenerative suppliers untitled letters (generally viewed as relatively less serious actions) while others like Invitrx get a full warning letter. It’s not always clear why. In this case is it because of the number and seriousness of the issues?

I expect more letters to suppliers of birth-related products including of unproven exosomes. My hope is that the FDA will soon do more than just send letters, particularly after the November expiration of their 3-year “grace period” ends for wide enforcement of their new regenerative policies.