A growing number of patients are heading to China for experimental therapies, such as cell transplants to treat spinal cord injuries and other diseases. But scientists in the field harshly criticize the trend, saying these therapies are costly, unproven, and potentially unsafe (see “The Problematical Dr. Huang Hongyun,” January 2005).
Now Wise Young, an internationally recognized expert in spinal cord injury, aims to address some of the problems associated with humans tests involving experimental therapies. He is spearheading a new project to conduct rigorous clinical trials in China and has set up a network of Chinese hospitals to test new treatments for spinal cord injury.
Young, a neuroscientist and director of Rutgers University’s W.M. Keck Center for Collaborative Neuroscience in Piscataway, NJ, says the availability of the enormous Chinese population will drastically speed up the clinical trial process, allowing new therapies to be tested more quickly and cheaply. He hopes the network will ultimately provide a go-to testing site for large pharmaceutical companies with new spinal cord injury treatments.
The number of potential new therapies for spinal cord injury has blossomed in the last few years – dozens of treatments have been shown to regenerate the spinal cord in animal models. But safely testing those therapies is a challenge. For one thing, spinal cord injury is a complex problem; patients often retain partial motor or sensory ability and may spontaneously recover some mobility after the injury.
“Something like blood pressure is easy to assess in a clinical trial – a pill either brings it down or it doesn’t,” says John Ditunno, a spinal cord injury expert at Thomas Jefferson University in Philadelphia. “But the challenge in spinal cord injury is that you’re looking at a person’s ability to function in real life. That’s very complicated.”
Clinical testing also requires many patients. With only about 10,000 spinal cord injuries in the United States each year, recruiting for a study is painfully slow. Trials for spinal cord injury treatments in the United States have been held up for years due to slow enrollment. As a result, frustrated patients, buoyed by success stories of experimental therapies not approved in the United States, have begun to travel overseas to gain access to these treatments.
One of best-known practitioners performing such treatments is Hongyun Huang, a controversial Chinese neurosurgeon who has transplanted in about 600 patients what he says are olfactory ensheathing cells, a type of cell that can help regenerate neurons.