November 28, 2020

The Niche

Knoepfler lab stem cell blog

Court empowers FDA to regulate stem cells as drugs

Are stem cells drugs?

stem cells drugs
Stem cells can be 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.

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