Second in a two-part series about stem cells. See the first entry here.
Aug. 13, 2019 -- Beverly Hills plastic surgeon Mark Berman says he can offer 12,000 reasons people should consider getting stem cell therapy at one of the clinics he co-founded across the country. That’s the number of patients he says his 100-plus affiliated clinics have treated for conditions like knee pain, erectile dysfunction, asthma, congestive heart failure, stroke, and Parkinson’s disease. Sports figures have also publicized the therapies.
But a number of stem cell scientists say that these and other self-described stem cell clinics are misleading the public. The treatments, which often cost $5,000 to $20,000, have no proof of safety or effectiveness. In many cases, there’s no logical scientific reason to think they might work, they say. And the procedures, which involve moving cells from one part of the body to another, aren’t really even stem cell therapies, according to scientists at Harvard University, New York University, the University of California, Davis, Arizona State University, the University of Minnesota, and others.
Stem cell therapies often involve taking cells from one area, like the abdomen, spinning them in a centrifuge to concentrate the cells, and then reinjecting them into another part of the body, like the knee.
Offering these procedures “violates the standards of medical practice,” says Insoo Hyun, PhD, a bioethicist at Harvard and Case Western Reserve University School of Medicine in Cleveland, OH.
Berman says the procedures that he offers are safe but adds that his clinics stopped providing stem cell shots into the eyeball after a woman treated for macular degeneration, a cause of age-related vision loss, had retinal detachments and went blind. Several other women treated elsewhere for macular degeneration were also blinded. Other reports blame stem cell procedures, mostly performed outside the United States, for tumors, infections, and brain inflammation.
Hyun says it may sound harmless to move your own cells around, but not all cells are the same. “Your body’s stem cells -- they’re found, they work, and they live in a very particular system,” he says. “When you transfer them out of that system, there’s no evidence they’re going to do anything except maybe cause harm because they’re in unfamiliar territory.”
Hyun says there’s no rational reason to try a stem cell therapy offered by one of these clinics, which are thought to number more than 700 across the country -- though he understands why desperate patients and families might be willing to take a risk for the promise of effective treatment. Some mainstream hospitals also offer stem cell and similar procedures, sometimes in the context of a research trial, sometimes not -- earning them the same criticisms as the clinics.
Hyun and others are quick to note that genuine treatments based on stem cells -- cells that can transform into different cell types -- have tremendous potential to eventually help patients with a wide range of ailments. But except for bone marrow transplants, which have been used for decades, and some research trials, which should be free to patients who volunteer, those treatments are not yet ready for patients, and certainly not for clinics in strip malls, Hyun says.
“If they would actually cure a devastating disease, we would all know about it,” he says.
Government Taking Action
The federal government has begun to crack down on these clinics, after largely ignoring them for years. The FDA has charged some clinics, including Berman’s, with selling drugs without appropriate approvals and with unsafe manufacturing practices.
In late June, a federal judge in Florida sided with the FDA against two clinics there. In a statement at the time, the government said: “Court decisions like this reaffirm the FDA’s compliance and enforcement efforts in the ongoing fight to protect the public from individuals and clinics who mislead patients with unapproved and potentially harmful medical products.”
Berman, who was not involved in the Florida case, has been sued by the FDA as co-founder of the California Stem Cell Treatment Center and the Cell Surgical Network. He argues that the federal government is overstepping its bounds by trying to regulate the procedures he offers.
He says he’s just giving patients back their own cells, not making a drug, so the FDA has no jurisdiction. A procedure like skin grafting, for instance, where skin from one part of the body is moved to cover a wound elsewhere, isn’t FDA-regulated.
“All I’m doing is giving you back your own stuff,” Berman says. “You own it.”
But the FDA says that when a product is created from a person’s own body, manipulated, and put back into the body, but for a different purpose, it could be considered a new product subject to FDA approval.
“Stem cell products can create unique and serious risks depending on how they’re manipulated once they’re taken from the body and how they are used once they’re reinserted in the body,” then-FDA Commissioner Scott Gottlieb, MD, and FDA Biologics Center Director Peter Marks, MD, said in April. “When a product undergoes more than minimal manipulation, its characteristics may be changed in a way that are novel, and its risks and potential benefits unique.”
Doctor Blames Bad Apples, ‘Special Interests’
Berman says that his procedures are very safe, and that the handful of injury lawsuits against stem cell clinics come from rare bad apples, or procedures that are no longer done.
Leigh Turner, PhD, a bioethicist at the University of Minnesota, says there’s no way to know how patients have fared, because no one has been keeping track. “Do we have a clear understanding of the number of people harmed by such procedures? I think the answer is: We probably don’t,” he says.
Stem cell clinics cloak their marketing in science, Turner and other scientists say. For example, they use proper scientific terms and fill their websites with explanations and links to scientific studies. Some clinics have patients sign waivers suggesting that their treatment is part of research. But most of these clinics have done little or no legitimate research, Turner says. Instead of publishing their findings in reputable, peer-reviewed journals where studies routinely change medical practice, these clinics publish in “junk journals,” if at all, he says.
Berman dismisses such scientific criticism. “These are misinformed PhDs working in their labs who have their own special interests,” he says.
Knee Shots Are Low-Risk, but Are They Useful?
The condition that Berman’s clinics treat most often is knee pain, and stem cell therapies may someday become the first line of treatment for patients with mild knee arthritis, says Philipp Leucht, MD, an orthopedic surgeon with NYU Langone Health in New York.
Injecting cells from the fat or bone marrow into the knee is generally safe, says Leucht, also a member of the American Academy of Orthopaedic Surgeons’ Biologics and Regenerative Medicine Committee. The main thing that could go wrong is an infection where you get the shot.
“It’s a low-risk procedure,” he says. “It’s expensive -- that’s the highest risk, probably, that you have to pay for it.”
But whether such shots are useful remains an open question. “The science is still weak,” Leucht says. There has never been a large, well-designed research trial, with patients getting the treatment compared to those receiving a placebo.
Some people with early-stage arthritis do seem to get pain relief with cell therapy, he says. (Leucht doesn’t believe in calling the procedures “stem cell therapies” because so few actual stem cells are in the fat or bone marrow that’s withdrawn and then injected into the knee. He prefers to call them “cell therapies.”) It’s not clear why some patients report improvements and others don’t, or how to target those most likely to benefit, he says.
Plus, Leucht says, any pain relief from cell therapy will likely be short-lived, because the relocated cells die off in a few days, and thus won’t stop arthritis from getting worse over time.
“This will be part of the future treatment for osteoarthritis, but we just have to understand it first,” says Leucht, adding that weight loss, exercise, and treating inflammation with over-the-counter medications and a healthy diet are already proven ways to reduce knee pain. “We can’t trial it on patients first and then figure it out [scientifically].”
What to Think About Before You Get a Treatment
The International Society for Stem Cell Research, a scientific group, publishes guidelines on its website to help patients decide what to consider when they’re thinking of getting treated at a stem cell clinic. Hyun co-wrote the most recent guidelines in 2016.
Before agreeing to treatments at stem cell clinics, you should ask questions about the procedure and the doctor performing it, say Emma Frow and David Brafman, both PhDs and assistant professors at Arizona State University. The pair helped co-author a study on the stem cell industry, published this month, that offered details about nearly 170 stem cell businesses in the Southwestern United States.
At those businesses, many specialists in orthopedics, sports medicine, and rehabilitation focused their stem cell treatments on conditions related to their specialty, according to the study, while specialists in cosmetic or alternative medicine were more likely to use cell therapies to treat a wide range of medical conditions. Next, the two say they want to examine the boards that are certifying some of these doctors as qualified.
But the lack of regulation and certification puts more pressure on patients to carefully consider the procedure and their doctor’s credentials, the pair says. Currently, Frow and Brafman say, the system is stacked against patients.
“They’re assuming all of the risk -- they’re assuming the personal risk, the physical risk, the financial risk,” Frow says. “We have a system at the moment really weighted toward benefiting the clinics, without a clear mechanism for benefiting patients and making sure they have recourse if things don’t go well.”
Turner agrees and thinks government regulators need to play more of a role. “We put too much on shoulders of individual patients, and we ought to be expecting a lot more from regulatory bodies,” he says.
‘We Will Beat the FDA’
Berman says he and others in the industry will continue to fight against tighter government regulations.
“We’re doing some amazing things, and we’re getting treated like we’re the scum of the earth,” he says. “I’m sick of it, and we will beat the FDA in the court as long as the judge is willing to listen to the law.”
But if the courts continue to uphold the FDA’s right to regulate stem cell clinics, many of the procedures that Berman and his peers perform today won’t be permitted.
That would transform the stem cell clinic industry, says Paul Knoepfler, PhD, a stem cell scientist at the University of California, Davis, School of Medicine, who tracks the field.
Some clinics might shut down, dropping out entirely, he says. For others, “the temptation to continue doing some kind of stem cell stuff might be too great.”
Knoepfler, a frequent critic of these clinics, thinks any reduction in their numbers would be good. “I think fewer people will be put at risk.”