Robert Vondracek has had multiple sclerosis for 20 years. His speech is starting to slur and he’s been having more trouble getting around, and when he heard about a controversial stem cell therapy that might help, he got excited.
“I heard about the stem cell treatments being done right here in Phoenix,” said Vondracek, 61. “It shocked me because it was not approved in this country, I didn’t think.”
The therapy was offered by an Arizona plastic surgeon who gives the stem cell treatments in the same clinic where he does cosmetic procedures.
But when Vondracek’s neurologist heard about his interest in the therapy, which would cost $7,000 per treatment, “He went crazy,” said Vondracek. He strongly advised Vondracek against it.
Plastic surgeons, other doctors and naturopaths at more than 100 clinics round the country are charging thousands of dollars for a controversial procedure called stem cell therapy to treat a range of disorders, including neurological diseases like MS and Parkinson’s.
The procedure has angered many neurologists and prominent researchers who say these doctors are preying on vulnerable people and capitalizing on the huge but still unrealized potential of stem cell research, which they say is years away from producing an approved treatment for neurological diseases.
“Peddling snake oil in the guise of stem cell therapies is really a threat to legitimate research,” said Dr. George Daley, director of the Stem Cell Transplantation Program at Boston Children's Hospital, past president of the International Society for Stem Cell Research and a professor at Harvard Medical School.
“Finding cures is hard, it takes sometimes decades, it's extremely expensive and it's not something that we can just wish and hope for,” he said. “It can only be achieved through very, very hard work.”
The stem cell therapy usually involves using liposuction to extract a patient's fat before separating out the stem cells using a centrifuge. The stem cells are then injected into the patient's blood stream the same day intravenously. Prices for this and similar treatments range from $6,000 to $20,000 per session.
The treatments have been popular in Europe and Asia for years, but until recently were unavailable in this country. But in the past few years, stem cell therapy clinics have cropped up in the U.S., and their numbers are increasing due to the franchise-like expansion of groups like the California-based Cell Surgical Network.
“We are growing,” said Dr. Mark Berman, a Beverly Hills plastic surgeon who was one of the Cell Surgical Network’s founders. He said he trained two doctors to perform the procedure just this week.
Dr. Steven Gitt , the Phoenix plastic surgeon whose services Robert Vondracek ultimately decided not to use, is also a member of the Cell Surgical Network. Gitt says he makes certain to tell his patients the procedure is not a cure and informs them they are participating in a study.
“We're doing it ethically and honestly. We are gathering good data and we are contributing and we are helping,” said Gitt in a recent interview with NBC News. He stressed that the procedure is safe and he knows of no patient who has been injured by it.
Gitt said that 60 to 80 percent of the people who receive the treatment have a positive outcome, meaning their quality of life is improved. When asked for neurological patients who had a positive outcome to interview, he suggested NBC News speak with Libby Aira, whose 41-year-old daughter Darian was hit by a car and suffered a traumatic brain injury eight years ago. Darian is unable to communicate.
“We did the stem cells and just a few hours later she reached for a glass of water on the right side, her affected side,” said Libby. “She couldn’t grasp or hold it, but just that intention of reaching for it was something we hadn’t seen.”
“Since then we’ve seen very slow little things. No big major steps -- I want her walking -- but now I see that happening [in the future],” said Libby.
But the neurologist who dissuaded Robert Vondracek from receiving stem cell treatment accused doctors who offer the treatments with “lining their pockets.”
“The only people who are benefitting are the clinics,” said Dr. Virgil DiBiase. He said that dozens of patients have called him about the treatments, which they find advertised on-line, and that the costs they cited sometimes topped $15,000. “Legitimate treatments are not marketed through YouTube or slick websites.”
“What’s a plastic surgeon doing treating a neurological disease?” he asked.
Dr. Daley, director of the stem cell program in Boston, said it was “dramatically premature” to charge patients “for a therapy we don’t yet know is safe or effective."
“I’m concerned that this this may actually be the pedaling of unproven treatments but masquerading as research,” said Daley.
“Our ability to know whether any of these interventions would work in actual MS patients is going to require rigorous clinical trials and a lot more hard work,” he said.
Dr. Gitt said he is performing the procedure to help his patients, and that he makes 90 percent or more of his income from his plastic surgery practice.
“What really excited and has continued to excite me about this field is that I kind of feel a little bit more like an old time real doc in that I’m really making amazing changes for people,” said Gitt.
Gitt said that he and other doctors using the technique are conducting a pilot study “to identify those conditions which will merit more vigorous prospective double-blind randomized type studies and go from there.” He said pharmaceutical companies and universities are not funding the procedure and that is why patients have to fund the study themselves.
Berman said the research scientists who are critical of the procedure are missing the forest for the trees.
“We are finding out stuff those guys will never find out because they’re stuck in the lab,” said Dr. Berman, who provided a handful of stories of people who have dramatically improved after the treatment.
“We’re not flying under the radar and I’m not apologizing to anyone. We’re doing investigative work. We have a huge online database. And we’re learning as we go along.”
He also countered critics who challenge the ethics of using a treatment that has not been sanctioned by federal regulators, or charging patients to participate in a study.
“We’re not flying under the radar and I’m not apologizing to anyone,” he said. “We’re doing investigative work. We have a huge online database. And we’re learning as we go along.”
Berman said his patients all know they’re part of an “investigative study” and “everybody signs informed consent.” He plans to apply for something called an Investigational Device Exemption from the federal Food and Drug Administration.
Under FDA guidelines, the procedure used by Berman and Gitt is not regulated because the cells are “minimally manipulated,” aren’t combined with other genetic material and the patient gets only his or her cells re-injected.
According to the FDA, the value of stem cells for most new applications is largely unproven, which can mean that patients forego effective therapies and instead are treated with unproven stem cell therapies.
“The safety of stem cell therapies for a variety of uses has not been assessed,” said a spokesperson for the agency. “Even stem cells isolated from a person’s own tissue can present … risks when put into an area where they are not performing the same biological function that they were originally.”
The agency said it is committed to supporting the development of new products to address unmet medical needs, including new applications for stem cell-based products. “It is important to understand that while the FDA works to make lifesaving treatments available to patients quickly and efficiently,” said the spokesperson, “the FDA is committed to assuring both the safety and the efficacy of the products it approves for use in the United States.”
“The FDA is concerned that the hope that patients have for cures which are not yet available may leave them vulnerable to unscrupulous providers of stem cell treatments which have not been evaluated for safety and efficacy and could potentially be harmful.”