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Stem cells lure ailing Americans overseas By CATHERINE CLABBY - Raleigh News & Observer Tim Maura had read the predictions that human stem cells could someday cure countless illnesses. "Someday" was too far away. He was disabled by heart trouble. Failed vessels blocked blood from reaching part of his heart. Surgery couldn't fix it. Chronic chest pain forced him to quit work in 2005. A year ago, Maura and his wife, Robin, cobbled together $30,000 and flew to Thailand, where doctors injected stem cells near his heart to try to sprout new blood vessels. While science is busy exploring the huge clinical promise of stem cells, some Americans contending with paralysis, multiple sclerosis and heart ailments aren't waiting. Like Maura, they are jumping to countries where regulation is less strict, despite real risks. "Based on the doctors that have examined me, there is just no other treatment available," said Maura, now 50, who returned to Raleigh, N.C., from Bangkok improved and this month found part-time work delivering auto parts. Some scientists warn against this trend. Stringent studies are vital to protect patients from unreliable research, the critics say. In stem-cell trials sanctioned by the U.S. Food and Drug Administration, some patients get an experimental therapy and others do not. Neither doctors nor patients know who gets what, so results aren't biased or distorted by a placebo effect. "The road to therapeutic development is scattered with the remains of therapies that really smart people thought would be good but did not work," said Northwestern University cardiologist Douglas W. Losordo, who is running a Food and Drug Administration-approved heart-stem-cell clinical trial. For sick people and their families facing bleak diagnoses, however, some risks are worth taking. Maura was very sick. He was never a candidate for bypass surgery, because his failed arteries could not be repaired. And Maura was not close enough to death to be eligible for a U.S. stem-cell study or a heart transplant. By fall of 2005, chronic chest pain forced Maura to leave his job managing a Jiffy Lube station. Just opening the garage bay doors was excruciating. Robin Maura didn't realize how badly off her husband was until she opened his dresser drawers and found stashes of empty plastic bottles of nitroglycerin, a drug used to open blood vessels to stem chest pain. A friend alerted Robin Maura to TheraVitae, a biotechnology company launched in Israel that develops stem-cell products. In Thailand, stem-cell treatments are not classified as drugs and government hospital ethical committees decide where they can be used. After tests involving eight patients, a Thai hospital in 2005 allowed physicians to use the cells on patients on an experimental basis, said Don Margolis, founder of TheraVitae Holdings. Since then, more than 160 patients have received TheraVitae cells in Thailand and Singapore. Experimental treatments in Taiwan and Hungary are in the works, he said. The Mauras flew to Bangkok in January 2006. Tim's stem cells were extracted from his blood in Thailand, manipulated at a laboratory in Israel and flown back to Bangkok, where surgeons threaded them into his blood system with a catheter and released them near his heart. He didn't feel better right away. But several months after his treatment, Maura was able to exert himself more without the chest pain. After being unable to walk a block, he can stroll more than a mile pain free. The couple racked up costs beyond travel and medical bills. Getting records from the United States to Thailand didn't always go smoothly. And Maura ruined any shot at enrolling in future U.S. stem-cell experiments. Still, Maura wants to return to Thailand for more cells. Stem cells harvested from human embryos are controversial because some people oppose destroying early-stage embryos to harvest them. But Maura received so-called adult stem cells, harvested from his own blood. The potential of adult stem cells excites scientists because their very purpose is to regenerate failed tissue and other body parts. Researchers believe they can create human repair kits by enhancing the cells. Success has been achieved building new blood supplies for children fighting some blood cancers, but most treatments remain experimental. Last year, TheraVitae won a World Economic Congress pioneer's award for its stem-cell technology. The company is preparing to seek government approvals to run standard clinical trials in the United States, Canada, Europe and Israel, said Valentin Fulga, a TheraVitae founder now based in Toronto. For now, TheraVitae reaches out to Americans with a Web site, offering its therapies as hope for people with serious heart problems who "cannot avail themselves of the latest medical technologies in their own country." It does make clear that success is not guaranteed. ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn