Across Chicagoland, at clinics which specialize in sports medicine, reconstructive and plastic surgery, even hair replacement, doctors are offering a new sideline: stem cell treatments for illnesses ranging from Parkinson’s Disease, to ALS and Multiple Sclerosis.
And the Food and Drug Administration isn’t happy.
“The value of stem cells as a treatment for most conditions is largely unproven,” the agency said in a statement provided to NBC5 Investigates, cautioning about the possibility of ineffective and potentially unsafe stem cell therapies.
Dr. Leigh Turner is one of the skeptics. A bioethicist at the University of Minnesota, Turner says he has identified at least 351 businesses, operating close to 600 stem cell clinics nationwide.
“These are usually people who don’t have meaningful credentials when it comes to stem cell research,” he told NBC5. “They’re making claims that have no empirical basis.”
The list of maladies the clinics say they can treat runs the gamut, from hair loss and orthopedics, to autism, dementia, and heart disease. At least nine such clinics are currently operating in the Chicagoland area, offering a variety of treatments.
“These are people who are suffering, and if I can do it inexpensively, why not?” asks Dr. Daniel Ritacca, a Vernon Hills-based cosmetic and reconstructive surgeon, whose clinic offers stem cell therapies for diseases ranging from COPD, to asthma, MS, Parkinson’s Disease and stroke.
“I’ve treated scores of COPD patients, and I haven’t had one complaint in their treatment yet,” he says. “They come in, I take good care of them, and I offer them what I think is cutting edge medicine right now.”
Ritacca insists he has seen dramatic results in heart patients and others suffering from multiple sclerosis.
“I’ve seen people moving their legs when they couldn’t move their legs,” he says. “I’ve seen people walking better---with one treatment.”
There are definitely customers. At two different seminars in the Chicagoland area, NBC5 investigates observed scores of mostly elderly potential patients crowding meeting rooms to hear sales pitches promising miraculous therapies.
But at the University of Minnesota, Turner scoffed at such claims, and said the FDA is not doing enough to police what he calls “stem cell snake oil.”
“These are not diseases and injuries that at present can be treated and cured with stem cells or other interventions,” Turner says. “There are no established stem cell treatments and therapies right now. They’re not available here in the United States, they’re not available anywhere in the world.”
Turner says he has tracked at least three cases involving serious injury. A Florida cardiologist lost his license after two patients died in his care. In a second case a woman sued a Florida clinic, saying she was left legally blind by a stem cell treatment designed to stop her macular degeneration. In that case, the lawsuit alleges the clinic’s chief scientific officer was in fact, a YMCA aerobics instructor.
Indeed, the Skokie-based International Society for Stem Cell Research urged caution.
“Many clinics offering stem cell treatments make claims that are not supported by a current understanding of science,” the agency states. “Currently very few stem cell treatments have been proven safe and effective.”
The agency, which represents thousands of stem cell researchers in 60 countries, said unproven stem cell therapies carry “very real risks”.
“Complications may create new short-and-long-term health problems, or may make your condition or symptoms more difficult to manage,” the organization warned in a statement on its website. “Out of pocket expenses could be enormous.”
Dr. Ritacca told NBC5 that his therapies run about $15,000 for three treatments.
“If I’m seeing 60, 70 percent of people saying this has helped me, I want more, what does that tell you?” he asked. “I still feel in my gut that I can deliver something. I still feel it—otherwise, I wouldn’t do it!”
Ritacca concedes that his therapies lack FDA approval, and he says he makes that clear to his patients. But he added that he genuinely believes the FDA is on the verge of expanding approval of stem cell therapies, and that he would like nothing better than to be reporting his results through proper channels.
“I’m in the trenches, I’m in the front lines,” he said. “I’m in a stem cell revolution.”
Turner argued that the clinics offer nothing more than false hope.
“The claims that they are making are incorrect,” he said. “Do they have any actual evidence? Or do they just want me to open up my purse or wallet and hand them a wad of money?”
So why isn’t the FDA doing more to stop it? The agency insists it is.
“When FDA has learned of information about clinics offering unproven stem cell treatments, the agency has been and remains actively engaged,” spokesman Andrea Fischer told NBC5.
In the meantime, Dr. Ritacca insists he has seen positive results. And that if a patient comes to him with a genuine need, as he put it, he’s willing to “give it a shot.”
“I see something coming that’s going to revolutionize medicine,” he said. “and as long as I can do it ethically, and not hurt patients, I’m all in!”