Boca Raton, Fla., parents Gary and Judy Susser say they know the hope and promise of stem-cell therapy. Nine years ago they traveled to Mexico for stem cell injections for their son Adam, who has cerebral palsy.
"Maybe it will do some good," Gary Susser said he and his wife thought at the time. They spent $25,000.
But the Sussers stopped stem cell injections in 2005, after spending about $25,000 and seeing no improvement. Today, armed with more information, the Sussers are grateful the treatments didn't harm Adam, now 12. While they are advocates of "responsible" stem cell research, they warn other parents against making trips to Costa Rica, Mexico, Russia or other offshore clinics for experimental treatments.
With promising breakthroughs making the news, as well as Internet hype, desperate parents and seriously ill patients may look to stem-cell therapy as the modern miracle that could cure them. And one day, stem cells may be routinely used to repair damaged cells, improve the treatment of diseases and even cure paralysis.
But there are hidden dangers to today's stem cell treatments, both in the U.S. and offshore, scientists said at the recent World Stem Cell Summit in West Palm Beach, Fla. They pointed to reports of deaths, tumors, lumbar punctures and other potential harm, as well as vulnerable people being conned out of thousands of dollars.
Patients are "buying hope," said University of Miami scientist James Guest, working on The Miami Project to Cure Paralysis. But he and other scientists say that responsible research takes years to complete. The Miami Project, in the making for 25 years, is just now reaching the human clinical trial stage, he says.
Scientists urge consumers look for regulated clinical trials at universities and research institutions, saying that even those are not without risks.
"Clinics are operating out of loopholes, a gray area disguised as the practice of medicine," said George Q. Daley, director of the stem cell transplantation program at HHMI/Children's Hospital in Boston.
Industry researcher Douglas Sipp has kept records of more than 400 companies advertising stem cell products or procedures on websites since 2007. When he rechecked this summer, Sipp said, 80 of the sites were no longer online, though they could have simply changed web addresses.
Some of the offshore clinics have been closed by individual countries after patients died, according to Sipp, who leads the research unit for Science Policy and Ethics Studies at the RIKEN Center in Japan.
Dr. Allan Wu, a plastic surgeon with California's Morrow Institute, says that consumers can be fooled by clinics using medical buzzwords like "autologous," which refers to stem cells coming from one's own body. Some clinics even claim on their websites that they are FDA-approved, which is untrue.
The FDA has only approved cord-blood stem cells products, being used in studies of leukemia, bone marrow disease and other blood disorders - no therapies have been approved.
In Florida, a stem cell treatment by a doctor is the subject of a trial.
State health regulators suspended the medical license of Bonita Springs, Fla., cardiologist Zannos Grekos after his 69-year-old patient Domenica Fitzgerald died in 2010. The patient had sought help for numbness in her feet. The state's lawsuit contends that the patient's medical records didn't justify Dr. Grekos' infusion of stem cells from bone marrow into the blood flow in the brain.
Grekos's attorney Richard Ozelie says the Department of Health's allegations are unfounded. He said Grekos is a "pioneer" in the stem cell field, providing stem cells from a patient's own body with "informed consent" by the patient. A judgment in the trial is expected in February.
Some doctors take the view that stem cell use in medical treatments is being used widely in other countries and that stricter regulations in U.S. may be slowing advances.
The Sussers say their son Adam started to track movement with his eyes after the first stem-cell treatment. Two eye surgeries followed and today he can pick out icons on an iPad. But Gary Susser doesn't know whether the stem-cell treatment or the traditional surgeries resulted in the improvement.
In Boca Raton, Fla., an orthopedic specialist, said he's making strides using stem-cells in repairing the knee.
"Run from anybody who says they're going to 'cure' your condition," said Dr. Joseph Purita, who has been doing the experimental stem-cell treatments for seven years.
Dr. Purita said he has treated "dozens" of athletes with stem-cell treatments in "every sport except hockey." The stem cells are drawn from the patient's own body, either from bone marrow or fat, and injected the same day in the joints.
"We haven't cured arthritis. We've found a way to make it better," said Dr. Purita.
In southern Florida, Mary Ellen Cook sought out Dr. Purita for stem-cell treatments in her knee, after hearing about a friend's success with it.
"I think it's wonderful," said Cook, whose family owns Hand's Stationers in Delray Beach, Fla. Cook, who is in her 70s, said her knee no longer hurts and she's able to play tennis three times a week.
"I'd go back and do it again," she said.
For more information on stem cell research, go to the International Society of Stem Cell Research's website, isscr.org.