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There are concerns about a growing industry that may be preying on chronically ill patients.
Hundreds of stem cell clinics have cropped up peddling injections, facelifts and treatments for devastating conditions.
All this while charging thousands of dollars and doing unapproved treatments that health officials say is nothing but quackery.
72-year-old Bob Wislow is more active than most. But the wear and tear on his body, specifically his knees, left him with arthritis and made it difficult to get around. Until he had a revolutionary procedure.
"I began to do stem cell treatments,” he said.
65-year-old Daryl McGee also had a stem cell treatment for his knee. But $4500 and months later, he's still limping in pain and has seen no improvement.
"I feel like I’ve been scammed,” he said.
Both men received stem cell treatments. Wislow by a noted Chicago orthopedic surgeon and McGee attended an all-day seminar that offered inspiring testimonials and a free lunch.
Dr. Mitchell Sheinkop is Bob Wislows surgeon. He often uses stem cells extracted from a patient’s bone marrow as an alternative to knee replacement. He's been keeping data as part of clinically approved FDA trials.
But Sheinkop is concerned there are too many unscrupulous for profit centers that are jumping into the regenerative medicine industry and making promises they can't keep.
"I find this almost scandalous there are such an entity holding seminars and promising patients false hope at huge expenses,” Dr. Sheinkop said.
Last year, the FDA warned that "the lack of evidence for unapproved stem cell treatments is worrisome." That's because not all stem cells are created equal and the only FDA approved treatment uses cells harvested from the blood or bone marrow from the patient’s own body, not from fat and not from amniotic fluid. That's what has the FDA concerned. It's worried questionable clinics are praying on patients desperate for pain relief or a miracle cure.
McGee says after attending a seminar he was told all he needed was one injection to his knee and he could be back to his active lifestyle. he admits paperwork he signed did read "results not guaranteed,” but he's angry because he says no one ever verbalized it.
So what's a consumer to do? Experts say make sure any stem cell treatment you consider is FDA approved or part of a clinical investigation plan allowed by the FDA. It appears Daryl’s was not.
Also make sure the doctor is board certified in this specialty and don't be afraid to ask for their scientific data that's been collected and asked if it's been published.
It's something Darryl wished he would have done.
FOX 32 reached out to the clinic that performed Daryl’s stem cell procedure for comment. The director told us Daryl is the first patient they have had that it did not work for. When we asked if he would get his money back, they wouldn’t commit but said they were working on taking a look at his case.
Also, in November, the FDA announced a new policy regarding regenerative medicine and warned clinics using illegal practices that they have 3 years to comply before they are fined or faced with possible prison time.