THE BEGINNING OF THE END OF THE FDA’S REGULATION OF AUTOLOGOUS STEM CELL TREATMENTS FOR ORTHOPEDIC USE
A little over a year ago, the FDA made public its final guidance documents in the stem cell field (HCT/P’s in FDA parlance). The documents were highly restrictive and all but eliminated the use of autologous stem cells outside of clinical trials. (I have written about this many, many times. Just scroll through some of my prior posts in the stem cell category on my home page). Apart from being wrong, my view has been that the FDA does not have the resources to eliminate private stem cell clinics.
More importantly, I predict that the standard of care is going to incorporate same day, autologous stem cell transplant way before there are completed clinical trials which shows drug level efficacy, irrespective of the FDA’s and the stem cell institutional opposition to so-called “unproven” stem cell treatment. I’ve been saying that HCT/P’s treatments for various orthopedic conditions will probably be the first such accepted use. Proof is now here!
A recent blog on the Niche laments the fact that the highly regarded and exceptional Swedish Medical Center (“SMC”) was now promoting autologous stem cell and PRP (Platelet-rich plasma) treatments for orthopedic conditions. https://ipscell.com/2019/02/swedish-medical-center/
Needless to say, these advertised uses fall on the wrong side of the FDA guidance documents. The post further laments the fact that this “is part of a bigger trend where more legit medical centers have begun selling regenerative medicine “treatments” that are still being developed.”
GAME, SET AND MATCH!
Now that SMC and a few other big players are doing it, the pressure will dramatically increase on other “legit” institutional players to offer similar treatments and do so in a more public way, via their web sites and promotional materials.
The six or seven hundred private stem cell clinics have no doubt been taking market share from the major orthopedic entities. The big places self-promote as providing cutting-edge, state-of-the-art, except that they haven’t been since the many of the major players have been slow to introduce HCT/P’s into their institutional practices. Market/competitive forces are not and will not allow that to continue. All the players are going to have to go all-in, or they will lose their competitive edge and be viewed as practicing last century’s medicine.
Right now the FDA’s blind eye to these big players can be justified by its statement in the guidance documents that it would give everyone three years to come into compliance except for the entities which create the greatest risk of harm (like the defendants in the two current FDA injunction lawsuits and the few others who have received warning letters in the last year).
There are two years left in the FDA’s grace period, but I predict that in that remaining time, “unproven” HCT/P use will increase in all areas, and will dramatically increase in the orthopedic area. Even now, but more so in two years, it will be too late for the FDA to try to reign in the orthopedists from providing HCT/P treatments to patients. The patient demand will be too great.
So what’s going to happen?
For sure: after the end of the three-year grace period, the orthopedists will continue to use HCT/P’s whether or not the use for any particular orthopedic condition has NDA drug approval.
The FDA will be forced to revisit its position, perhaps by a select committee of major hospital practitioners (not the lettered stem cell institutionalist organizations), perhaps via a revision to the draft guidance documents of what constitutes homologous use and more than minimal manipulation.
But here is the most likely scenario:
The FDA will simply post a notice that it will continue to exercise its enforcement discretion and not stop HCT/P use for all or most orthopedic conditions. I’d look for that to happen in at least one other HCT/P use as well. This way, the FDA can save face and still maintain its jurisdiction over these folks and their procedures.
In short, the fact that entities like the Swedish Medical Center and a few others are now advertising HCT/P treatments for orthopedic use means that such use will quickly become the standard of care and the practice of medicine, which will make these procedures untouchable by the FDA, notwithstanding the agency’s flawed guidance documents.
That’s my prediction anyway.
Rick Jaffe, Esq.