BOSTON (CBS) – Desperate patients are paying thousands of dollars for stem cell treatments that critics say have not been subjected to full scientific review.
The Food and Drug Administration is now evaluating the way this growing industry is regulated.
Charisma Cardine has been blind for 10 years, losing her sight to a rare neurological disease. Her family cobbled together $9,000 for stem cell therapy they believed would restore Charisma’s sight.
“I thought this was it. I was going to be able to see,” said Cardine. “They told us it was a 90-95% success rate.”
The Hellers were desperate to get Robert off his oxygen machine. COPD has left him struggling for every breath. “We were grasping at straws, but we would do anything to help him, and they were very optimistic this would work,” said his wife Diane about stem cell therapy which claims to generate new lung tissue.
The Hellers spent $7,000 on the treatments.
Neither Heller or Cardine got the result they wanted. “They’re making statements and promises that can’t be kept,” said Heller.
“It sounds too good to be true,” said Dr. David Scadden of the Harvard Stem Cell Institute. “The problem is that people are given mostly a hope, and then something that doesn’t have any realistic possibility of helping them. I think it’s terribly exploitative.”
There have not been any clinical trials showing stem cell therapy can provide relief in these situations.
There are powerful testimonials, however, showing patients with positive outcomes. Bob Leonard had stem cell therapy for MS. “I am walking better. I am walking faster. I am more balanced that I used to be.”
Dr. Daniel Ritacca, Leonard’s doctor, has now handled 4,000 cases. He says he is careful to keep expectations in check. “I do not tell them this is a therapy. I do not say cure.”
Historically, the Food and Drug Administration hasn’t taken a strong stance on these treatments. Since the stem cells are removed from a person’s body and then put back in, they have been treated differently than a new drug or medical device coming on the market.
In Dr. Jafar Koupaie’s Canton office, he removes a patient’s fat with liposuction and then concentrates the stem cells in a special machine.
The resulting solution is then re-injected for breast augmentation and other cosmetic procedures.
Dr. Koupaie learned these techniques at a clinic in Japan.
“This is the safest procedure you can do because you are not adding anything to your own fat cell,” explained Dr. Koupaie. “Basically, you are moving the fat from one area, cleaning it up, putting it another area of the body. There is no need for the specific procedure to have FDA approval.”
The FDA is now taking another look at these types of stem cell therapies however. It recently sent a warning letter to two large clinics questioning the procedures they perform.
More oversight could be a good thing for families like the Hellers.
They got swept up in a wave of optimism when there wasn’t much hope. “They didn’t promise 100% that this was going to happen. However, they made clear it was working for a lot of people.”