Stem Cell Centers to fall under FDA oversight

POST FALLS — A chain of North Idaho clinics plans to continue performing treatments without any change in procedures after a judge ruled the practice now falls under the supervision of the federal government.

As part of a ruling against a different chain of clinics, a federal judge in Florida ruled Monday that because clinical procedures often inject stem cell materials into patients, those materials are for all intents and purposes drugs, which authorizes the Food and Drug Administration to regulate the practice.

“The ruling basically says that a person falls under control of the FDA,” said Travis Autor, chief executive officer of Stem Cell Centers, a clinic chain headquartered in Post Falls. “The government now has us in control — completely. I think the narrative of this should be, ‘Do I really want the government in charge of my tissue and in charge of my body parts?’”

Autor, who founded Stem Cell Clinics seven years ago, said the ruling does not impact any procedures currently being performed at his eight clinics.

“We’ve been following FDA guidelines on this from the start,” Autor said. “We follow the same practices they recommend, we use the same equipment they recommend. It’s important people understand: What we’re doing is not illegal. The FDA has given us guidelines on this for quite some time. We still follow those guidelines. We still have the data they ask for to back up these procedures, and we still take part in the studies they require. All this ruling does is really clarify who has oversight.”

Monday’s ruling against one of Autor’s competitors, U.S. Stem Cell Clinics, impacts the Post Falls company because it, too, administers extracted patient fat, isolates certain stem cells from the sample and then injects the patient with those cells. The procedure is used to treat a range of neurological, autoimmune, and orthopedic illnesses. Autor said joint pain is a common complaint.

Medical professionals do not unanimously concur with Autor.

“[The federal ruling] is good news,” said Dr. Chuck Murry, chair of the University of Washington’s Institute for Stem Cell and Regenerative Medicine in Seattle. “Most of us in medicine have always felt this was a long time coming. Some of these clinics are fly-by-night, putting patients at risk. This ruling now puts some teeth into the FDA’s mandate to serve as the people’s watchdog over these kinds of clinics.”

Murry didn’t specifically call out Stem Cell Centers but cast doubt over the industry as a whole.

“There’s a spectrum,” he said in a phone interview with The Press. “Of course, stem cell therapies can be very beneficial. We can look at other regenerative medicines like platelet-rich plasma and see the benefits. But the 95-plus percent of these procedures being performed in pop-up stem cell clinics are just a bunch of hooey. These procedures have no basis in evidence and no basis in theory. They defy logic and swindle people through hope.”

Murry added that many who step into stem cell clinics can often find themselves not just patients, but victims.

“A lot of people are in chronic pain,” he said. “There’s a real unmet health need, and that’s the problem that’s at the heart of this. Because they’re in pain, they become targets. The way we humans are, when we have people who are desperately ill, other people will prey on them. That’s just Life 101.

“The people we see? Often times, the medical community has otherwise failed them. Because of over-regulation and outright greed, some patients aren’t covered for these treatments, or they don’t qualify for certain treatments …

“We’ve treated over 10,000 patients, and we’ve given away over $3 million in hard costs to help our patients. We wouldn’t be doing any of that if this treatment didn’t work. The proof is in the pudding.”

While Autor resents the new federal oversight, he said he will continue to comply with FDA guidelines and what will eventually become FDA requirements.

“The important thing is to continue to be honest and up front with our patients,” he reiterated. “We have to continue to inform our patients about the procedures, the success rates, the risks. We have to use FDA-approved products during our procedures. The FDA doesn’t consider this an illegal treatment. Everything they will require of us, we’ll continue to do.”