What is up with the stem cell company, Precision StemCell, these days?
I can’t imagine they are exactly celebrating after having been reported to the FDA. They also have apparently moved operations from the US to Colombia at some point recently.
What’s the deal here? First, a little background is helpful.
You can read that February 21, 2012 letter here. I believe it was a key milestone event in the history of stem cells.
I was not a fan of Celltex’s practices either and had written a piece on them and RNL Bio on February 29, 2012 (I’m not sure, but I believe I had not yet learned at that time about Turner’s letter).
A few months after Turner’s letter the FDA paid a visit to Celltex (actually a two week audit) and within months of that all clinical transplants of stem cells related to Celltex were shutdown after a sternly worded FDA warning letter. It is very important to note that Celltex threatened Turner and the University of Minnesota with litigation as a result of the letter written by Turner.
Turner and his institution did not back down.
In the stem cell field, Turner is widely considered a hero for having the guts to stand up to a stem cell business that he believed was putting patients at risk. For example, he won runner up for my blog’s 2012 Stem Cell Person of the Year Award. On March 5th and March 12th of 2012 I wrote pieces strongly supporting Turner and his colleague Carl Elliott.
I had never met them at that time, but admired what they were doing.
Now, Turner has published a piece about a letter he recently wrote to the FDA about another stem cell company, Precision StemCell, that to his way of thinking may warrant some regulatory attention from the FDA. I highly recommend this piece to you as worth your time to read, but I will summarize key points of it and the letter to the FDA.
Turner writes in his letter to the FDA that the leader of Precision StemCell, Dr. Jason Williams, promotes stem cell interventions for a wide range of conditions.
In the FDA letter Turner says:
Many individuals have undergone adipose-derived stem cell interventions at Precision StemCell. It is imperative that such purported stem cell-based interventions are confirmed to be safe, efficacious, and in compliance with federal regulations before they enter the commercial marketplace and are used to treat patients. I am therefore hoping that you will investigate the regulatory status of stem cells administered to patients at Precision StemCell.
Turner also raises concerns about non-homologous use of stem cells by Precision StemCell and the treatment of a minor, a little boy. It seems that the treatment of this 5-year old ended up in what seems to be a promotional video for the company.
Remarkably, Turner in addition reports that the company has therapeutically employed some kind of “stem cell reprogramming technique” using a drug called Seligilene to treat a 74-year old man with ALS. The details of this “reprogramming” are scarce, but it is alleged that the process changes fat stem cells into neural stem cells. If correct, such a process would surely seem to be beyond the definition of “minimal manipulation” established by the FDA and hence make the end product a drug subject to thorough FDA oversight PRIOR to administration to any patient.
Turner also goes on in the letter to the FDA to highlight a number of other concerns including the medical devices and kits used by the company.
In Turner’s blog piece he notes that Dr. Williams and Precision StemCell should come under the scrutiny of the FDA and the Alabama State medical board. Turner also argues that Williams was essentially engaging in non-compliant, unlicensed human experimentation:
If Dr. Williams wants to conduct research addressing safety and efficacy of adipose-derived stem cell injections for ALS he should have first submitted an Investigational New Drug application to the FDA and then waited until the FDA let the proposed study proceed or imposed a clinical hold. Instead, it appears that Dr. Williams began injecting adult stem cells into individuals without first submitting an IND application to the FDA or seeking to have a research protocol approved by an IRB. For over a year Dr. Williams has engaged in unapproved, unauthorized human subjects research. Over twenty individuals paid substantial amounts of money to Dr. Williams for these unproven, experimental stem cell interventions.
What comes next?
If history with the Celltex experience is any indication, it would seem that Dr. Williams and Precision StemCell could have possibly expected an FDA visit (no indication itself of any wrongdoing necessarily of course) in the coming months, but now that possibility is unclear with the company’s exit from the US.
Dr. Turner may get some blowback from the company, which could even include threats of litigation. However, it is difficult to see on what legal basis the company could successfully sue him.
More generally, frequently companies in this kind of situation do not in fact litigate against critics because they are afraid of the discovery phase producing inconvenient facts about their business. Of course in this case I have no specific knowledge one way or another.
Stay tuned as this story is likely to heat up more in the near future.