Are stem cells drugs?
At least for today, a federal court unambiguously ruled that the answer to this question for manipulated stem cells is “Yes”.
The story has been reported in the media at New Scientist and Scope Blog. You can read over the key issues here.
The court ruled in favor of the federal government and FDA and against Regenerative Sciences, Inc. (RSI), finding that manipulated stem cells are drugs.
What does this mean?
I believe that the federal court just ruling has at least temporarily delivered a major blow to for-profit stem cell clinics that grow their stem cell products prior to administration to patients. The clinics I mean are those that work against the FDA. I believe clinics that are working with the FDA and following regulations deserve our support. It’s an important distinction.
Back to the case…
New Scientist quoted Dr. Christopher Centeno of RSI, who vowed to appeal,
“This is really round one,” he says. “Our position remains that a patient’s cells are not drugs.”
A few months ago I interviewed Centeno and Doug Sipp about many of these issues in what turned out to be a fascinating piece that I highly recommend. Another super interview with great relevance to this case is one I did just recently with industry expert, Lee Buckler.
Chris Scott of Stanford, head of the Program on Stem Cells in Society at Stanford, was quoted as follows by Scope:
“I think it’s a good ruling, and I’m glad to see that that the FDA has exercised its muscle on the case,” says Christopher Scott, who heads the Program on Stem Cells in Society at Stanford University in California.
Scott hopes that the FDA will now step up its efforts to regulate other clinics offering unproven stem cell therapies. These include Celltex of Sugar Land, Texas, which rose to prominence after Texas governor Rick Perry was injected with stem cells supplied by the company to aid his recovery from back surgery.
Centeno is right that this ruling is not an absolute end to this legal and regulatory battle. However this ruling is absolutely bad news for clinics hoping to administer stem cell products grown in culture as a “practice of medicine” rather than as drugs.
One such clinic is Celltex. Their stem cell product used to treat Perry has reportedly been given to at least 80 other patients and the cells were grown prior to transplant.
In the new world of today such products are drugs.
Bottom line?
In my opinion, stem cell clinics are now embedded in a less ambiguous legal and regulatory reality. Barring some future legal surprise, the wiggle room to administer manipulated stem cell products to the patient has vanished.
With this precedent most experts I’ve talked with today don’t expect it to come back. We are in a new reality.
The hundreds of Doctors doing adipose manipulation under the table will not risk his/her State MD license. S vs S has halted hESC funding and IMO so will this injunction halt “some” of the under the radar practices of MSC’s and Adipose. the FDA 361 Blood-Loop-Hole is gone… The massive exodus to friendly neighbors to the South is now in full swing.
JTG
http://www.investorstemcell.com
It seems to a layman an odd ruling in that, if my manipulated stem cells are a “drug” subject to FDA regulation how could they be tested?
A stem cell therapy in itself might be tested. But my own cells, modified, are not going to make any sense as a double blind study.
I have to assume that the real question here is not about a particular set of stem cells but rather about the efficacy of a stem cell based treatment.
An interesting point–what is the control for the study of this kind of cellular drug?
Key points are efficacy AND safety.
Does the term “manipulation of stem cells” also encompass “concentration of stem cells”? What, exactly, does “manipulation of stem cells” entail?
Concentration of cells via a number of methods including centrifugation is to my knowledge not considered beyond minimal manipulation.
Great 2nd question–here’s some background: https://www.ipscell.com/2012/03/minimally-manipulated-cells-maximally-manipulated-human-guinea-pigs/.
Paul, thank you for this post. Regarding Texas, I guess the ball is in the FDA’s court. Apparently, Texas companies must apply for an IND or similar approvals to allow biological drugs, as defined and determined by the FDA, to be used by Texas physicians in approved clinical studies. I think the good Texas companies will work with the FDA to bring safe and effective therapies to patients and keep research moving forward.
Thousands and thousands of medical procedures that were risky have been supervised successfully in the past through state medical boards. History is crystal clear on this one – there is no alternative method superior to having new medical procedures progress and allowed in the market more quickly than state medical board approvals. They help thousands of these procedures reach millions that are sick, terminally ill, or disabled more quickly.
The court’s new ruling is saying that the FDA has the right to regulate this medical procedure as a “drug,” which are cells manipulated from a patients own body. Following their own protocols from their past, the FDA has never categorized any human body part or cells as a “drug” and have these treatments mandated to the same arduous phases of clinical drug trials. You may ask why? Simple, the FDA has former pharmaceutical executives on the board along with advisors that are ex-pharma executives, and they will conveniently, see adult stem cells as a drug for their own best interest. Not to mention, since big pharma cannot bottle or shelf autologous stem cells, they will never pursue this revolutionary medical procedure for research and profit. Why, because it is a medical procedure and not a manufactured chemical drug! You can’t bottle a medical procedure. The irony of it all, undisclosed, big pharma sees it as a medical procedure. This decision without a shadow of doubt is meant to protect the billions of dollars of drug sales!!!