Stem-Cell Refugees

Yanks are flocking to China for therapy

August, 2002. Chuck Melton, a burly 24-year-old factory worker, is living a good life in southern Illinois. He has a growing family: Son Blake is 3 and daughter Bailey is 1. An outdoorsman, Melton fishes, hunts deer, and rides four-wheelers at all-terrain-vehicle parks. Today he has gone for a swim with some friends in a local lake. His pals dive in, and then Melton does, too. But something is wrong about the way he enters the water. Instead of dipping lightly beneath the surface like the others, he strikes his head on the bottom.

A few hours later, at a hospital in St. Louis, he receives the grim news: His spinal cord is severely injured, and he is paralyzed from the chest down. In the ensuing months, he learns what life is like in a wheelchair, suffering uncontrollable leg spasms 20 to 30 times a day. The injury also affects his body’s internal controls. He loses the ability to perspire, so he can’t be outside during the summer months for more than a few minutes.

GOVERNMENT SUPPORT
Flash forward 4 1/2 years. Melton is in Shenzhen, a city in Southern China. He has checked into Nanshan Hospital for a treatment that will place him on the frontiers of modern medicine. In the operating room, Chinese doctors have put a needle into Melton’s spinal cord and inserted stem cells isolated from umbilical cord blood. Their goal is to accomplish what no doctor in the U.S. has done: to give Melton hope that his condition is not permanent. “I would love to be able to walk again,” he says. “But I look at anything as an improvement.”

One week into his treatment, he’s pleased with the results. His leg spasms have pretty much disappeared, and during the acupuncture treatment he can feel heat in his muscles. “It is an absolutely wonderful and blessed feeling,” he writes in his blog, “to continue to see and feel small changes of recovery.”

The treatment that Melton is getting is unavailable in the U.S. but increasingly popular in China. In this nation, “stem cells” aren’t fighting words. Doctors don’t debate the ethics of destroying day-old embryos to harvest the cells. And with the tacit support of government regulators, physicians are more adventurous than Western doctors in treating patients with stem cells extracted from aborted fetuses and from umbilical cords.

In the U.S., doctors have only injected small groups of people with stem cells from fetuses or cord blood as part of clinical trials. And even in test environments, the most versatile embryonic stem cells aren’t used on humans because they’re too hard too control. In animal tests, stem cells have been known to morph into tooth and hair cells–something you definitely don’t want in a heart or a brain. It could be years before the U.S. Food & Drug Administration gathers enough data to declare stem-cell therapies safe and effective. Not even celebrity advocates such as Michael J. Fox or the late Christopher Reeve have argued for waiving trials in order to treat patients right now.

Many doctors in the West therefore believe patients like Chuck Melton should stay put in the U.S. The Chinese doctors can’t prove their treatments work because “they don’t have statistically valid sample sizes and there are no control subjects,” says Dr. John D. Steeves, professor at the University of British Columbia and co-author of a recent paper in the journal Spinal Cord, which offers guidelines for clinical trials involving stem cells. “The way Chinese doctors are doing this means nobody will learn anything,” he complains. “It won’t help them, it won’t help us, it won’t help the medical community.” Dr. Robert Lanza, vice-president for research and scientific development at Advanced Cell Technology, an Alameda (Calif.) company that is a leader in embryonic stem-cell research, says he’s “very concerned…. A lot of patients could get exploited. To go overseas for therapies that are not up to standards required in countries such as the U.S. could be dangerous.”

Chinese doctors insist the concerns are overblown. Experience has already shown there’s no danger with umbilical cord stem cells, argues Dr. Sean Hu, chairman of Shenzhen Beike Biotechnology Co., a company that works with Nanshan Hospital to provide Chuck Melton with his treatment. “We’ve done all the safety studies,” says Dr. Hu, who compares what he and other Chinese physicians are doing to bone marrow transplants. “If the doctor is qualified and the hospital is qualified, then they should be allowed to do this.” In addition to helping patients, Hu believes his work will give China a competitive edge in an important new area of medicine. And he talks about building a global network, with centers in Latin America and Eastern Europe.

SUCCESS STORIES
Good or bad, China’s clinical work is already cutting-edge. More than 100 Chinese hospitals are currently performing stem cell procedures, according to Jon Hakim, a Minnesota native who has been appointed director of the foreign patient services department at Beike, helping Nanshan Hospital recruit patients. Since opening up to foreigners about a year ago, Beike has treated 170 of them from 29 countries. Like Melton, most of them find out about Beike from the Internet, and many write their own blogs in China and after they return home. In addition to spinal cord injuries, doctors treat Multiple Sclerosis, cerebral palsy, and Ataxia, a genetic disease that leads to deterioration of muscle function. While undergoing stem cell treatment, patients may also receive Physical Therapy, acupuncture, massage, drugs, and electrical stimulation. The average price tag: $17,000, plus airfare.

Melton and his fellow patients have heard the warnings from Western doctors. But they have also read about Beike’s success stories, and with doctors at home not offering them any hope, they’re willing to take their chances and ignore the critics. “People like that, they’re not living with what I’m living with,” says Rachel Lane, a former schoolteacher from New South Wales. She has ataxia and had to give up teaching when the illness caused her to slur her words. “People think I’m drunk,” she says bitterly.

Dr. Hu contends that doctors have an obligation to help such patients. “If you say wait [for clinical trials], these patients will lose the chance,” he says. To meet the objections of Western doctors, though, he is now hoping to start clinical trials for his treatment. “We know it is safe and effective. Now we’re going to prove it,” he says.

Western doctors may be difficult to persuade. Dr. Susan Perlman, a clinical professor of neurology at University of California at Los Angeles, cared for one patient before and after his stem-cell treatments in China. She confirms there were modest but medically significant improvements, but the results didn’t last. Perlman notes that the multifaceted nature of the treatments patients receive in China makes it hard to assess the benefits from stem cells. With ataxia patients, for example, “it is well known that improvements can be achieved with aggressive physical therapy,” she says. Stem cells also carry certain risks, Perlman says, noting that brain tumor growth was observed in a patient with Huntington’s disease who was treated with fetal stem cells.

Chuck Melton isn’t hesitating. He describes one night, shortly after his first injection, that he woke up with a feeling he hadn’t experienced in years. “My pillow was wet, my hair was wet, my neck was wet,” he says. For the first time since his accident, Melton was sweating. “I almost had tears in my eyes.” Melton will complete his treatment before Chinese New Year in mid-February. And despite the well-grounded scientific concerns of Western doctors, he’s already planning a return visit next year.

By Bruce Einhorn, with Arlene Weintraub in New York