Thanks to a murky regulatory system in the U.S., rogue clinics are springing up across the country where doctors are concocting treatments made from stem cells found in the fat that is pumped out of the body during liposuction and are using it to treat conditions ranging from Parkinson’s disease and lupus to arthritis and cardiac problems. But do these treatments work? Are they safe?
The Associated Press (AP) has published a must-read article about a popular new treatment that relies upon the use of Adipose Derived Stem Cells (ADSC) that are suctioned out of a patient’s backside or abdomen, processed in a special machine, then injected back into the body to heal a variety of ills.
The technique was pioneered in South Korea and Japan to enhance face lifts and breast augmentation but has come to the U.S. where doctors, such as former Beverly Hills cosmetic surgeon Mark Berman, MD, is using it to treat patients for all kinds of conditions.
Berman runs the Cell Surgical Network and adapted “processing” equipment and techniques from Asia to come up with his own lipsuction-based procedure.
Berman’s Network is now the largest stem cell chain in the country with 67 locations and more than 100 doctors operating in 22 states.
“Doctors who join the network generally charge about $9,000 per procedure,” the AP reports, and buy South Korean cell-separating machinery and other equipment from Berman for anywhere from $25,000 to $30,000.
The equipment is used to make a “soup” out of blood and fat that is then injected back into a patient’s body.
“I don’t even know what’s in the soup,” says Berman. “Most of the time, if stem cells are in the soup, then the patient’s got a good chance of getting better.”
This is risky medicine, to say the least!
“ . . . (W)hile 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,” the AP reports.
“It’s sort of this 21st century cutting-edge technology,” says 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 says he’s about to publish a 1,000 page study demonstrating the safety of his treatments. Even if this study ever materializes, he’s so heavily invested in the procedure the report will hardly be considered objective enough to pass scientific scrutiny.
But that isn’t stopping patients from flocking to these clinics and signing waivers acknowledging that they are participating in an experimental medicine. These informed consent forms require them to assume all the risks involved and to cover the full cost of the procedure which is not covered by insurance.
The risks are substantial. Consider the case of Dr. Zannos Grekos, a cardiologist in Bonita Springs, Florida, who specialized in using stem cells to treat debilitating diseases. He treated a patient named Richard Poling, who came to him for treatment for his breathing problems. Grekos told the family the treatment would put Poling “back on the golf course the next day” because the $8,000 treatment would regenerate his lung cells.
Grekos harvested fat from Poling’s abdomen and sent it to an off-site processing facility to isolate the stem cells. Later that afternoon, an assistant infused the resulting mixture into the patient’s blood stream. Poling suffered a cardiac arrest and was pronounced dead after being rushed to a local hospital.
Poling wasn’t the only patient to die at the hands of Grekos who eventually lost his medical license and moved to the Dominican Republic where he continues his business. He believes none of his patients died because of the treatment and that he’s being targeted by the state in order to discourage doctors from working with stem cells.
So how are these doctors getting away with it? They can operate in this country only because the state medical boards tasked with licensing and disciplining health professionals simply aren’t policing the industry as they should.
“State sanctions against stem cell doctors are rare because medical boards generally begin investigating practitioners only after patients have been harmed,” the AP reports. “That’s led many industry critics to conclude that regulation must come from the FDA, which regulates experimental drugs and medical products on a national level.”
Unfortunately, the FDA’s regulatory authority regarding stem cell procedures is not clearly defined and has been the subject of debate by legal experts for years. As the AP reports, they have only cracked down on a handful of clinics. The agency is far more concerned with how much processing the stem cells undergo and if they should be subject to regulation as prescription drugs. The kind of “minimal manipulation” taking place at these same-day stem cell clinics is not defined in FDA guidelines.
Fortunately, the FDA is beginning to take action and has released draft guidelines dealing with these procedures but it could be years before those guidelines are finalized.
In the meantime, consumers should be aware that no matter how scientific a clinic’s site might appear, they are taking their lives into their hands by submitting to these treatments.