Surgeons agree on guidelines for stem-cell operations.
It's hard to get a bunch of prima-donna surgeons to agree.
Earlier this month, around 60 of China's top orthopaedic surgeons and neurosurgeons met at a military hospital in the southwest provincial capital, Kunming. Over three days of discussion and joint operations on two monkeys, the surgeons reached a consensus on how and where incisions should be made to transplant materials in spinal-cord treatment. “It's hard to get a bunch of prima-donna surgeons to agree,” says Wise Young, a neuroscientist studying spinal-cord injuries at Rutgers University in Piscataway, New Jersey. “We need to have them roll up their sleeves and do it.”
Young, originally from Hong Kong, is preparing a network of surgeons to address a big problem in China: maverick doctors, pushed by growing medical tourism, are increasingly transplanting cells or drugs into injured spines despite having only anecdotal support for their effectiveness. There is also little rigorous follow-up of the patients, so although many procedures are done, the field does not advance. But Chinese local and national governments are increasingly requiring doctors to use clinically proven procedures. “People are starting to demand data,” says Young.
Young's network — called China SCINet and based in Hong Kong — aims to provide those data. Its first major trial will test a combination therapy of lithium and stem cells. Starting in 2008, the team will transplant umbilical-cord stem cells to around 400 patients. Half of the patients will also receive lithium, which stimulates the growth of neurons, in the same oral doses as those prescribed for manic depression (L.-W. Yick, K.-F. So, P. T. Cheung and W. Wu J. Neurotrauma 21, 932–943; 2004). The idea is that the stem cells will provide a 'bridge' at the injury site, which new axons can grow on. Twenty centres in the network are already doing an observational study on the patients who will be in the trial, to get a baseline from which to judge improvement from the therapy.
Young also hopes to involve industry. He is negotiating with pharmaceutical companies to provide a third element to add to the mix — drugs known to block the chemicals that inhibit growth of neurons.
Young says that he has two main reasons to work in China. The number of patients living with spinal-cord injuries has increased over the past decade, which Young attributes to the growth of the automobile market and better care, which keeps patients alive longer. China now has more of these patients than any other country. In addition, it is fast and cheap to run trials there. Large numbers of patients gather in relatively few hospitals, making recruitment easy. “You can get hundreds, or even thousands, of patients at a single centre,” says Young. And the cost of surgery and after-care is about US$20,000 per patient in China — about a fifth of that in the United States. The combination therapy in the trial will be preceded by preliminary studies on lithium and umbilical-cord transplants separately, the first of which will begin next month. Together, the trials will cost just US$12 million.
The 2008 trial will be the first controlled study for spinal-cord injury in a country where doctors have increasingly been transplanting all kinds of cells. The most famous example is Hongyun Huang from Chaoyang Hospital in Beijing, who has performed hundreds of procedures in China after working with Young as a postdoctoral student at Rutgers (see Nature 437, 810–811; 2005 and 440, 850–851; doi:10.1038/440850b 2006).
These studies tend to claim that the treatments are effective, often on the basis of patient testimony, without peer review or any rigorous follow-up. Huang is now carrying out trials with fetal Schwann cells, fetal olfactory cells and a combination of the two, which he says have a strong scientific basis. But his critics remain sceptical. Huang has “had a thousand or so chances so far to acquire scientific data”, says James Guest, a neuroscientist with the Miami Project, a huge spinal-cord-injury research centre at the University of Miami in Florida, referring to the number of patients Huang has treated.
Guest says he hopes that Young's network will “standardize spinal-cord injury care within China”, adding that “a success of this venture could do a lot to establish China as a credible place to do multicentre trials”.
Young's reputation, including his work with one of the first successful treatments for spinal-cord injury, methylprednisolone, should set the project in good stead. “There is no doubt that he can run a clinical trial,” says John Steeves, director of the International Collaboration On Repair Discoveries at the University of British Columbia in Vancouver.
But there are concerns that the procedure and follow-up must be high level and consistent across the trial. “Having a lot of patients does not necessarily mean you can test them all in a controlled, valid manner,” says Steeves. And Guest worries whether a cultural aversion to admitting problems might hamper data sharing: “Will the adverse events really be disclosed?” he asks. Some spinal-cord clinicians also suggest that more animal data should be collected for lithium and umbilical cells before moving to humans.
Young says he knows that the difficulty will now be in the trial's execution. But he argues that even establishing a network in a country where harsh competition makes researchers and doctors hesitant to collaborate is a huge achievement: “They used to say, 'no way, I'm not letting Dr so-and-so come into my hospital'. But now they are pooling resources and setting up joint teams.”
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Cyranoski, D. Chinese network to start trials of spinal surgery. Nature 446, 476–477 (2007). https://doi.org/10.1038/446476b
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DOI: https://doi.org/10.1038/446476b