December 26, 2017 Richard Jaffe

http://rickjaffeesq.com/2017/12/26/y...ne-stem-cells/

Itís time to look back at what happened this year, and make some predictions about next year. Part One will focus on stem cells.

We started 2017 awaiting the FDAís final guidance documents on HCT/Pís (ďstem cellsĒ). In late August, the FDA foreshadowed the guidance documents by issuing warning letters to two of most high profile (or infamous) stem cell clinics in the country. Both clinics were warned that their use of HCT/Pís were in violation of the FDA trifecta (unapproved new drug, misbranding and adulteration), and that their facilities were not in compliance with applicable good tissue and manufacturing practices.
Here is my post about it:

http://rickjaffeesq.com/2017/09/22/s...-cell-clinics/

Within two months of the warning letters, the FDA published the final guidance documents. They were at least as bad (from the perspective of these clinics and the patients which seek out non-FDA approved stem cell treatments) as the draft guidance documents.

See my prior post analyzing the final guidance document:

http://rickjaffeesq.com/2017/11/17/b...-cell-clinics/

On the other hand, two states passed stem cell legislation. California passed a meaningless law aimed at providing informed consent to patients.

See my post at:

http://rickjaffeesq.com/2017/10/05/c...ange-anything/

Texas passed a stem cell law which could allow patients to use both autologous and allogenic stems cells therapeutically (or in FDA parlance, ďnon-homologouslyĒ).

The law wonít open-up the floodgates because of the relatively high barriers to entry (i.e., the cost of an ambulatory surgical center, and the big-time IRB requirements), but as Iíve said, as long as the Texas Medical Board doesnít mess it up, Texas could become the Mecca for the therapeutic use of stem cells.

here is my post about it:

http://rickjaffeesq.com/2017/05/31/l...s-legislature/

And yes, Congress did pass some legislation involving stem cells, but it just deals with supposedly faster approval. It wonít cause a single patient to receive stem cell treatments in 2018, or so is my prediction. The bill was just a tactic to get stem cell advocates off of Congress folksí back.

Finally, last week, a civil lawsuit was filed against the Florida clinic which has become the poster child of the ďgreedy and evilĒ for-profit, heretofore unregulated stem cell industry. These are the folks that had a nurse practitioner inject HCT Pís in the eyeballs of patients and allegedly caused blindness or reduced vision. Thatís bad news for them and all of the stem cell clinics in the intermediate term. Itís going to take a while for the case to reach any meaningful result. But the institutional stem cell Mafioso will surely keep banging the drums about this case to keep the pressure on the FDA to do more.

Whatís going to happen in 2018 in the stem cell field?

For sure, the FDA will try to pick-off a few more clinics by starting the process of inspections, issuing 486 field reports, and then following-up with warning letters. I expect to see one or more of the recipients of these warning letters to be involved in litigation with the FDA. However I donít expect any court rulings until at least mid to late 2018. As I said before, if the first case decided involves the Florida clinic involved in eyeball injections, the stem cell field wonít like the result.

Are private stem cell clinics going to disappear from the US in 2018?

Absolutely not! If anything I think 2018 will bring more options to patients in terms of use of their own stem cells and even umbilical cord stem cells and other HCT/Pís.

You might ask how I can possibly think this in light of the final guidance documents and the FDAís recent warning letters?

I think the delivery of these new therapies is going underground. My read is that more and more physicians are quietly using HCT/Pís in their practice. Therefore, I think that in 2018 and beyond, more people will have access to these treatments, but not necessarily through the large, high profile stem cell only clinics, because some of them will be mired in legal battles with the FDA.

Wonít the FDA shut all of these stem cell docs down?

I donít think so because the FDA doesnít have the resources or infrastructure to eliminate the clinical use of stem cells.

More in the weeds: more doctors are using stem cells in their clinical practice. The FDA isnít equipped to go after all of these practitioners, because its structure, resources and operations are geared towards drugs, not the practice of medicine. (And the practice of medicine just happens to be the best defense these docs have, albeit, not recognized by the one case in which it was raised, but more about that another time).

Equally important, patient demand is too great, and more and more physicians are seeing the dramatic benefits of these treatments.

I predict that many more docs will start using stem cells because of these two factors, and FDA be dammed. Ultimately, I predict that the popularity and the anecdotal evidence of success will prevail over the FDA and the stem cell Mafioso. So while the FDA may pick-off a few of the large, high profile or infamous clinics, I think there will be as good, if not better access to these innovative treatments in 2018. That is my prediction and hope.

Richard Jaffe, Esq.
Rickjaffeesquire@gmail.com