BEVERLY HILLS, Calif. — The liquid is a mixture of fat and blood. Dr. Mark Berman pumps it out of the patient, treats it with a chemical, runs it through a processor — and injects it into the woman’s knees and elbows.
The “soup,” he says, is rich in 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 said. “Most of the time, if stem cells are in the soup, then the patient’s got a good chance of getting better.”
It’s quackery, critics say. 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. 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 facelifts.” The cost ranges from $5,000 to $20,000.
Although stem cells from bone marrow have become an established therapy for a handful of blood cancers — and while there are 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 one stem-cell doctor who has had two patients die under his care.
“It’s sort of this 21st-century cutting-edge technology,” said Dr. Paul Knoepfler, a stem-cell researcher at the University of California at 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.”
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. Berman calls it “liquid gold.”
Today, the Cell Surgical Network is the largest stem-cell chain in the nation, with 67 locations that include Denver and Boulder, 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.
The stem-cell clinics, though, promise results far beyond those 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,” said Dr. George Daley, a founding executive of the Harvard Stem Cell Institute and professor at Harvard Medical School.
Berman calls his business model “patient-funded research” and said he plans to soon publish the results of a 1,000-patient study demonstrating its safety.
Leigh Turner, a professor of bioethics at the University of Minnesota, said charging patients to participate in medical research is unethical. He calls the approach “unauthorized, for-profit human experimentation” and has asked the Food and Drug Administration to investigate Berman.
The regulators tasked with weeding out dangerous medical practices are the 50 state medical boards responsible for licensing and disciplining health professionals. 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. The group fined Welker $10,000 and revoked his license.
State sanctions against stem-cell doctors are rare because medical boards generally begin investigating practitioners only after patients have been harmed. That’s led many industry critics to conclude that regulation must come from the FDA.
But the FDA’s authority to regulate stem-cell procedures is not clearly defined.
The key issue in FDA’s oversight of cell-based medicines turns on how much processing the stem cells undergo. According to FDA regulations, human cells that are more than “minimally manipulated” are subject to the same regulations as prescription drugs.
Now, the FDA appears to be stepping up its oversight. In the last days of 2014, it released draft guidelines dealing with these procedures. The agency said that processing fat into stem cells for medical use is more than “minimal manipulation,” essentially creating a new drug. The guidelines have not been finalized — a process that can take years.
The FDA declined to make officials available for an on-the-record interview for this story. But in a statement, it said it “takes violations of the regulations seriously and routinely follows up on entities producing products that potentially violate FDA regulations.”
