The number of stem-cell clinics across the United States has surged from a handful in 2010 to more than 170 today, many linked in large, for-profit chains.
BEVERLY HILLS, Calif. —
The liquid is dark red, a mixture of fat and blood, and Dr. Mark Berman pumps it out of the patient’s backside. He treats it with a chemical, runs it through a processor — and injects it into the woman’s aching knees and elbows.
The “soup,” he says, is rich in shape-shifting stem cells — magic bullets that, according to some doctors, can be used to treat everything from Parkinson’s disease to asthma to this patient’s chronic osteoarthritis.
“I don’t even know what’s in the soup,” Berman says. “Most of the time, if stem cells are in the soup, then the patient’s got a good chance of getting better.”
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It’s quackery, critics say. But it’s also a mushrooming business — and almost wholly unregulated.
The number of stem-cell clinics across the United States has surged from a handful in 2010 to more than 170 today, according to figures compiled by The Associated Press. Many of the clinics are linked in large, for-profit chains. New businesses continue to open; doctors looking to get into the field need only take a weekend seminar offered by a training company.
Berman, a Beverly Hills plastic surgeon, is co-founder of the largest chain, the Cell Surgical Network. Like most doctors in the field, he has no formal background in stem-cell research. His company offers stem-cell procedures for more than 30 diseases and conditions, including Lou Gehrig’s disease, multiple sclerosis, lupus and erectile dysfunction.
There are clinics that market “anti-aging” treatments; others specialize in “stem-cell face-lifts” and other cosmetic procedures. The cost is high, ranging from $5,000 to $20,000.
Berman and others point to anecdotal accounts of seemingly miraculous recoveries. But while stem cells from bone marrow have become an established therapy for a handful of blood cancers — and while there are high hopes that the cells will someday lead to other major medical advances — critics say entrepreneurs are treating patients with little or no evidence that what they do is effective.
Or even safe. They point to the deaths of two patients under the care of one stem-cell doctor.
“It’s sort of this 21st-century, cutting-edge technology,” says Dr. Paul Knoepfler, a stem-cell researcher at the University of California, Davis. “But the way it’s being implemented at these clinics and how it’s regulated is more like the 19th century. It’s a Wild West.”
Doctors in South Korea and Japan pioneered the fat-based stem-cell technique, using it to supposedly enhance face-lifts and breast augmentation. For years, U.S. patients would travel to hospitals in Asia, Latin America and Eastern Europe — places where regulation is more lax than in the United States — to have these procedures as part of the international “stem-cell tourism” trade.
Plastic surgeons in the United States quickly realized the financial potential of the fat they were already taking out of patients’ bellies and backsides through liposuction — something that had been disposed of previously. Berman calls it “liquid gold.”
Some early adopters have expanded into chains, offering doctors across the country a chance to join the franchise after buying some equipment and attending a seminar.
One national chain markets itself online with accounts of celebrity athletes who have been treated with its stem-cell procedures. Prospective patients are then directed to a call center, where sales representatives try to match them with stem-cell doctors over the phone.
Berman spent more than 30 years as a Beverly Hills cosmetic surgeon before co-founding the Cell Surgical Network in 2012. He and his business partner, a urologist, adapted equipment and techniques from Asia into a liposuction-based procedure.
Today, the Cell Surgical Network is the largest stem-cell chain in the nation, with 67 locations and a roster of more than 100 doctors in 22 states. Doctors who join the network generally charge about $9,000 per procedure; they pay Berman and his partner $25,000 to $30,000 for a South Korean cell-separating machine and other equipment.
Stem cells have long been recognized for their ability to reproduce and transform into other cell types. Because of their ability to repair and replace tissue, they are thought to hold potential for treating many diseases and injuries.
Embryonic stem cells are the most versatile because they have the ability to form all the various cell types in the body, but their use in medicine is considered controversial by some because it involves the destruction of human embryos.
Adult stem cells are less versatile but can be easily harvested from various tissues in the body, including bone marrow and fat. For decades, they have been routinely transplanted, first in bone-marrow transplants and then in procedures that transfer the cells alone. They have been useful in combating leukemia, lymphoma and other blood diseases, saving the lives of tens of thousands of people each year.
The stem-cell clinics, though, promise results far beyond those now considered prudent by mainstream medicine.
“I think responsible professionals have a broad consensus that marketing of these unproven interventions is premature and unprofessional, if not unethical,” says Dr. George Daley, a founding executive of the Harvard Stem Cell Institute and professor at Harvard Medical School.
Julia Matsumoto, of Fountain Valley, Calif., claims stem-cell injections have helped maintain her eyesight four years after being diagnosed with chronic relapsing neuropathy, which causes inflammation of the optic nerves and can lead to blindness.
Berman has treated her on a monthly basis since 2012, free of charge, because Matsumoto cannot afford repeat procedures. Berman liposuctions fat from her abdomen, then processes it with a spinning centrifuge machine and a drug, before filtering it and infusing the mixture into an injection site in Matsumoto’s chest.
“Things were so vivid and bright literally 30 minutes after the stem cells were given to me,” Matsumoto says, recalling her first treatment. “I started crying on the way home.”
Hard to evaluate
Such patient anecdotes are not considered reliable medical evidence. And because stem-cell clinics have not published large, rigorous studies of their techniques, it’s virtually impossible to evaluate their record of success.
Berman calls his business model “patient-funded research,” and says he plans to soon publish the results of a 1,000-patient study demonstrating its safety.
But Leigh Turner, a professor of bioethics at the University of Minnesota, says charging patients to participate in medical research is bizarre and unethical. He calls the approach “unauthorized, for-profit human experimentation,” and has asked the Food and Drug Administration to investigate Berman, arguing that his business amounts to selling unapproved, experimental drugs.
The clinics insist that their treatments are safe but routinely require that patients sign waivers.
The regulators tasked with weeding out dangerous medical practices are the 50 state medical boards responsible for licensing and disciplining health professionals. But those groups have taken action against only a handful of stem-cell doctors.
Last year, the Oregon Medical Board revoked the license of Dr. Kenneth Welker, a Eugene physician who performed at least five experimental stem-cell procedures. In one case, a 62-year-old woman who received a spinal injection of stem cells experienced tingling, elevated blood pressure and rapid breathing, according to the board’s complaint. The group fined Welker $10,000 and revoked his license, citing “unprofessional or dishonorable conduct.”