In Beverly Hills, a clinic says it can help athletes heal from sports injuries and avoid invasive surgeries by employing regenerative stem cells.
In Miami, another clinic says it can reuse stem cells from patients’ bodies to erase wrinkles.
And in Sacramento, a clinic’s website has NFL wide receiver Marlon Moore touting the relief he felt after undergoing stem cell treatment from local doctors.
All of those clinics are part of a growing industry that promotes what its advocates describe as low-risk alternative treatments for conditions that range from nerve damage to cosmetic surgery.
Yet they’re also operating outside of the normal realm of medical oversight from the Food and Drug Administration by carrying out procedures that have not been tested and sanctioned by the agency.
A new study published Thursday in the journal Cell Stem Cell by UC Davis professor Paul Knoepfler and a partner from the University of Minnesota is drawing attention to the increasing number of clinics in the U.S. that offer stem cell therapies not approved by the FDA.
Using extensive internet searches, Knoepfler and bioethics professor Leigh Turner found 351 businesses promoting those services at 570 different clinics. California is home to 113 of them.
It’s a striking number that illustrates the reach of what Knoepfler and his partner describe as a largely unregulated industry that has not yet collected enough clinical data to prove whether its methods are safe and effective.
“Most of these businesses kind of took the shortcut route,” Knoepfler said. “They decided we’re not going to do any trials and we’re going to take the stem cells directly to the people.”
He and his partner are wading into a national debate about how the government should regulate new procedures five years after famous athletes such as retired Broncos quarterback Peyton Manning and Mets pitcher Bartolo Colon turned to stem cell treatments for their injuries. Most of the clinics operating in the U.S. have opened since then.
In 2004, California voters approved an initiative funding stem cell research in the state. Since then, the California Institute for Regenerative Medicine has allocated about $2 billion for research.
You don’t have to drive to Mexico anymore. You can just drive down the street and get a stem cell treatment.
Knoepfler and Turner want the FDA to rein in the industry so patients have a better understanding that they’re seeking procedures that have not undergone extensive scientific tests to determine whether they work. They also argue that compelling stem cell procedures to undergo the full FDA approval process could protect the industry by ensuring its practices are safe.
“The problem is that so much of the information that’s provided by the industry, so many of the marketing claims being made, they’re not particularly accurate,” Turner said. “They’re not trustworthy, and they don’t have any meaningful science behind them.”
So far, the FDA has taken a fairly light touch regulating clinics that provide stem cell therapies. It issued draft guidelines to regulate the industry in 2014 and in September it’s holding a public hearing at the National Institutes of Health in Maryland to gather opinions on how it should regulate stem cell treatments. The federal agency also issued a warning letter in 2012 urging people to be critical of clinics that promote stem cell treatments.
“At this time, the value of stem cells as a treatment for most conditions is largely unproven, and more information is needed about their potential benefits,” FDA spokeswoman Andrea Fischer wrote in a statement to The Sacramento Bee summarizing the agency’s stance.
Most stem cell procedures involve taking cells from a patient’s body and reintroducing them to the same patient, which means they’re not considered a drug that would be regulated by the FDA. The agency, however, could choose to regulate them as a practice.
Clinics popping up around the country have some influential backers encouraging the FDA to refrain from compelling all stem cell procedures to undergo the expensive and lengthy approval process the agency uses when it considers new medications or medical devices.
We do believe in the healing power of stem cells and offer them to you in advance of any potential scientific discoveries that may support their efficacy.
nervana stem cell centers
In May, for instance, the leader of the taxpayer-funded stem cell research program California Institute for Regenerative Medicine joined former Senate Majority Leader Bill Frist, R-Tenn., in writing an opinion piece for Fox News that urged the FDA to find an alternative approach to regulating many new stem cell treatments.
Institute President Randy Mills told The Bee that Knoepfler’s research highlighted a “broken system” at the FDA that lets some clinics proceed with almost no oversight while requiring others to undergo studies that could tie up their services for decades. He said there are likely far more clinics offering stem cell therapies than Knoepfler and Turner identified, with many of them operating discreetly.
“There’s so much stuff going on today, but it’s going because that’s the system the FDA set up and that’s the system the FDA incentivizes,” he said.
On Capitol Hill, a small group of lawmakers including stroke survivor Republican Sen. Mark Kirk of Illinois is advancing a bill, the Regrow Act, that would provide a quick path to FDA approval for some stem cell treatments by waiving the last phase of FDA-mandated clinical trials. The bill has not yet had a committee hearing.
At the Sacramento clinic, nervana stem cell centers, doctors acknowledge in a disclaimer that the procedures they carry out have not been approved by the FDA.
“We do believe in the healing power of stem cells and offer them to you in advance of any potential scientific discoveries that may support their efficacy,” the doctors wrote. An official from the clinic was not available to comment for this story.
Although famous athletes continue to promote stem cell therapies, some news outlets recently have focused on patients who experienced setbacks after stem cell procedures.
One of them was a 66-year-old San Diego man who allowed his doctors to document his troubles in the New England Journal of Medicine earlier this month. After stem cell procedures that he sought out in China, Argentina and Mexico, Jim Gass developed a painful mass on his spine that constrained his movement. His doctors told The New York Times they could not entirely remove the mass.
To Knoepfler and Turner, Gass’ story underscored their call for the FDA to more rigorously regulate stem cell clinics in the U.S.
“You don’t have to drive to Mexico anymore,” Knoepfler said. “You can just drive down the street and get a stem cell treatment.”