With few regulations, stem cell clinics booming
BEVERLY HILLS, Calif. — More than 170 clinics across the country are selling experimental stem cell procedures for dozens of diseases and conditions — a mushrooming industry that has flourished despite little evidence of its safety or effectiveness.
The rise of the US stem cell industry illustrates how quickly fringe medicine can outpace government oversight. Over the last five years, academic stem cell researchers have watched in dismay as doctors treat patients with experimental techniques they say could take years, if not decades, to become sound medicine.
‘‘It’s sort of this 21st century cutting-edge technology. 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,’’ says Dr. Paul Knoepfler, a stem cell researcher at the University of California Davis.
Stem cells have long been recognized for their ability to reproduce and regenerate tissue. And while there are high hopes that they will someday be used to treat a range of debilitating diseases, critics say stem cell entrepreneurs have little more than anecdotes to support their offerings.
In 2010, there were only a handful of doctors promoting stem cell procedures in the United States, mainly plastic surgeons promoting ‘‘stem cell facelifts’’ and other cosmetic procedures. But today, clinics throughout the country are promoting stem cells for dozens of conditions and diseases, including Alzheimer’s, arthritis, erectile dysfunction, and hair loss. The prices are high, ranging from $5,000 to $20,000.
Many of the businesses are linked in large, for-profit chains that offer doctors the chance to join the franchise after taking a seminar and buying some equipment.
The largest is Cell Surgical Network, cofounded in 2012 by Dr. Mark Berman, who spent 30 years as a Beverly Hills plastic surgeon before working with stem cells. His company offers stem cell procedures for more than 30 diseases and conditions, including Lou Gehrig’s disease, multiple sclerosis, and arthritis. He and his partner adapted technology from Asia into a liposuction-based procedure in which fat is pumped out of a patient’s abdomen, processed with drugs and equipment, and then injected back into the body.
Berman says this fat-based ‘‘soup’’ is rich in shape-shifting stem cells that have the potential to treat everything from neurological diseases to achy joints.
‘‘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.’’
The clinics insist their treatments are safe, but routinely require patients to sign waivers.
State actions against stem cell doctors are rare. That has led critics of the industry to conclude that regulation must come from the FDA, which regulates medical products on a national level. But the FDA’s authority to regulate stem cell procedures is not clearly defined and has been debated for years.
Yet the FDA appears to be stepping up its oversight. In the last days of 2014, it released draft guidelines dealing with the popular fat-based stem cell technique. The agency said that processing fat to extract stem cells for medical use essentially creates a new drug that cannot be sold in the United States without the agency’s approval.
But many stem cell doctors continue to argue they don’t need FDA permission because they are performing in-office surgical procedures, not creating drugs.
For now, Berman has no plans to change his business.
‘‘How is it unethical if you’re actually helping people, even if we don’t have evidence-based studies to prove it?’’ he asks.