Stem cells. Those two words muster up notions of controversy and miracle science.

The science “hasn’t really caught up,” said one expert. There’s not a lot of science behind it and many people seem to be “jumping the gun.”

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But an increasing number of athletes are using regenerative stem cell therapies in the U.S. — although the Food and Drug Administration has yet to approve them.

“In the U.S., none of this is FDA-approved,” said Paul Knoepfler, a University of California, Davis biologist and noted stem cell blogger.

These therapies involve adult stem cells — not the controversial embryonic stem cells. While there are many types of therapies, the two main adult stem cell therapies gaining mainstream use include Platelet Rich Plasma (PRP) and stem cells from fat, said Knoepfler.

With PRP, blood is drawn and the platelets are extracted, then put back into the body to trigger healing via stem cell growth — sort of like fertilizer being added to a lawn. Because the blood is minimally manipulated and the FDA has approved devices to separate platelets, it’s not a regulated drug but is considered a procedure.

Removing stem cells from fat tissue involves more manipulation, and the FDA tends to view this as more of a drug it should regulate, said Knoepfler. But again, it has yet to do that.

“It’s pretty extensive what you have to do to get the [stem] cells out of the fat,” Knoepfler added.

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Dr. Eckhard Alt, a professor at Tulane University in New Orleans, Louisiana, said adult stem cells are specific to certain organs and tissues (embryonic stem cells are not, making them more flexible though highly controversial).

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Here’s how they work. When older stem cells in the body are exhausted or non-existent, the injection of undamaged stem cells into a specific organ or tissue can regenerate growth.

Athletes and Average Joes
“It has become pretty popular it seems for athletes,” Knoepfler said. “It’s almost sort of like a viral trend.”

Athletes including hockey legend Gordie Howe and football players Chris Johnson and Merril Hoge — and Peyton Manning, reportedly — have used the therapies. One caveat: The treatments aren’t exactly proven to work, despite all the rage. The science “hasn’t really caught up,” Knoepfler said. There’s not a lot of science behind it and many people seem to be “jumping the gun.”

Athletes, however, aren’t the only ones going for stem cell treatments, he added. Each day, dozens of people get stem cell treatments across the U.S. And as the buzz grows, the belief is that more will follow. Treatments run anywhere from $10,000 to $25,000 per session, depending on the therapy, and are not covered by insurance.

“Today, the majority of our patients are average Joes or Janes,” said one orthopedic surgeon.

Many clinics are located in Texas, Florida, and California, said Knoepfler, and even if a state medical board approves them, the FDA still has ultimate authority — assuming it takes a stance.

“One could say these doctors [who provide treatments] are challenging the FDA by what they’re doing,” said Knoepfler.

Texas allows treatments that have been reviewed and are for research purposes, Alt added.

Dr. Michael Swartzon, an orthopedic surgeon at Miami Orthopedic and Sports Medicine Institute, provides stem cell treatments using donor amniotic fluid. The pre-screened tissue, he said, is from a lab is registered with the FDA, with the American Association of Tissue Banks, and is licensed in the state of Florida.

“This is a much simpler process than traditional methods,” he told LifeZette. When more conservative therapies are not effective, physicians consider the patients for the treatment.

His patient base started as only professional athletes, but last year he treated more “everyday” people. “Today, the majority of our patients are average Joes or Janes,” said Swartzon.

FDA’s Role
There’s been a big push for the FDA to establish its role regarding to stem cells. It issued some guidance last year, but nothing was defined. In 2011, it approved the first stem cell product, Hemacord. It uses umbilical-cord blood to treat disorders of the hematopoietic, or blood forming, system.

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In March of this year, Sen. Mark Kirk and his colleagues introduced the REGROW Act, which has been referred to committee. Knoepfler said it would drastically weaken FDA regulation of experimental adult stem cell therapies, essentially giving them a free pass. Along with other organizations including the Cystic Fibrosis Foundation and National MS Society, he opposes it.

Last Thursday, the International Society for Stem Cell Research released new guidelines. “Potential benefits are sometimes exaggerated and the challenges to clinical application and risks are often understated,” they said. “Inaccurate or incomplete representations of this sort can have tangible impacts on the expectations of the general public, patient communities, physicians, and on the setting of health and science policies.”

Stanford University researchers reported last week that seven out of 18 study participants had improvements in post-stroke abilities with the help of stem cell therapies. The lead author told The Washington Post that a 71-year-old wheelchair-bound woman was able to walk again. He said he was over-cautious about “selling” the results.

Some therapies are in clinical trials run by the FDA. It will take another five to 10 years to see therapies approved, Knoepfler believes. Alt said it could be one or two. Until then, treatments being performed are not clinically tested.

“I worry about the risks,” Knoepfler said.