From the outside, the Chaoyang Hospital looks nothing like a state-of-the-art medical facility. The pavement outside the old red-brick building is broken, while patients inside lie on hospital cots in grim, dark hallways. Despite its appearance, the hospital has become a magnet for patients with spinal cord injuries, amyotrophic lateral sclerosis (ALS), and Parkinson disease from all over the world. They come to find neurosurgeon Huang Hongyun, who is using fetal tissue transplants in the hope of repairing neurological damage.
Over the past 3 years, Huang told The Scientist, he has used fetal tissue transplants to treat more than 450 patients. He now has 1000 Chinese and foreign patients on a waiting list, including about 100 Americans, who find him via the Internet or word of mouth. He has also used the procedure to treat strokes, multiple sclerosis, cerebral palsy, and brain injuries with, he says, “equally positive results.” The bulk of his Huang’s patients are people suffering from spinal cord injury, followed by ALS, a distant second. He has only treated a few patients with Parkinson disease.
Huang uses olfactory ensheathing glial cells (OECs) extracted from the olfactory bulbs of fetuses aborted during the second trimester of pregnancy. These cells are thought to have the capacity to regenerate damaged nerve fibers, and although research groups elsewhere are conducting human trials with adult versions of the cells, Huang’s group is virtually alone in using fetal tissue. The neurosurgeon’s team cultures the cells before injecting them into the patient. For ALS patients, three incisions are made, two in the frontal lobe and the third at the spinal cord around mid-neck. Spinal cord injury patients get injections in the spinal cord close to the site of injury. “If you look at an MRI of an ALS patient, you’ll see that the greatest atrophy is in the frontal lobes,” Huang said. He thus injects the OECs at the point closest to the area of damage.
The transplanted cells do not replace neurons, but help the neuronal axons to regenerate, and this brings about improvements in the conditions of patients, Huang told The Scientist. “OECs don’t replace neurons,” he said. “It’s the glial cells that provide an environment in which damaged neuron cells recover.”
“I don’t know how it works, but I know it helps patients,” the neurosurgeon admitted. “But the clinical evidence shows that it can help. And if I’m wrong, we wouldn’t be achieving these results.”
About 1 to 1.5 million cells are injected per injection site, Huang told The Scientist, so patients with spinal cord injury receive a total of 1-1.5 million cells, while those with ALS receive up to 4.5 million cells. He said patients often regain some movement or feeling 2 to 3 days after the procedure. There was no evidence that injecting more cells would attain better results, he added. An Australian group had done a similar procedure on three patients, giving 10 injections and injecting 10 to 15 million cells. “I believe this is dangerous,” he said. “It’s a large volume and not good for the spinal cord.” Animal research using OECs for spinal cord injury is conducted in the United States, but the human transplant procedure is not available. Scientists feel the evidence is not strong enough to support human use of the technique. Plus, research using fetal and embryonic tissue is restricted.
“There’s no moral majority in China ruling scientific research, and that’s a big factor,” said 33-year-old ALS patient Ben Byer, who was diagnosed in 2002 and operated on by Huang on July 20.
The published evidence in support of Huang’s work is skimpy. No controlled clinical trials have been carried out, although Huang said he’s talking with the Miami Project to Cure Paralysis about designing such studies.
“We are evaluating his work and determining what next steps would be appropriate, if any,” a spokesman for the Miami Project told The Scientist. In fact, two physicians from the Miami Project are currently in Beijing for 10 days to gather information on Huang’s procedure and to evaluate the progress made by patients.
Wise Young, a research professor at New York University’s medical school, told The Scientist Huang’s work was interesting. “His results represent a credible phase 1 trial that establishes the safety and feasibility of such transplants. Preliminary analyses of the results suggest that the procedure may produce rapid but modest sensory and motor improvements in people from 2 to 40 years after injury. These results await confirmation with more rigorous controlled trials.”
Huang himself does not claim a miracle cure. With spinal injury patients, he said, neurological functions can improve, but he expects no complete recovery. With ALS, “If the process can keep them stable, that’s already pretty good.” In the Chinese Medical Journal last year, Huang published a report showing results in 171 spinal cord injury patients, 2 to 8 weeks after transplantation. The study used the International Standards for Neurological and Functional Classification of Spinal Cord Injury scale, which gives a best total score of 100 for motor function and 112 for pin-prick (light-touch) sensation. Huang did not report baseline scores, but after OEC transplantation, motor scores increased by 8.3 in patients aged 21 to 30 years and 5.7 in those aged 31 to 40 years, he reported. Light-touch scores increased by 15.5 and 12.0 in the same groups.
Jake Giambrone, 18, was paralyzed following a wrestling accident 3 years ago and has lost all ability to move his body. Just 2 days after he underwent the transplant in Huang’s operating room, I watched as Jake struggled to move his thumb and as he talked about feeling muscle spasms for the first time since his injury. “It may not seem like much to you all, but he hasn’t moved in 3 years,” said Susan Giambrone, Jake’s mother. “We’re real excited about the thumb.”
Cade Richardson, 31, underwent surgery on Monday for paralysis that resulted from a paragliding accident in 2001.
Richardson heard about Huang from another patient. He communicated with Young, who he says cautioned him to wait another 6 months before trying the procedure. (Young, who studies OECs in mice, also moderates a CareCure chatroom for spinal cord injuries where a lot of news about Huang’s research is discussed). But when Richardson started hearing more success stories coming out of China, he decided to go ahead.
“It’s going to be another 5 or 6 years before anything happens in the United States,” Richardson told The Scientist. “I don’t want to wait another 5 or 6 years.”
Dr. Perlmutter’s comment:
Bottom line, there is very little to offer ALS patients. While it is reasonable to be skeptical, we should not deny ALS patients any opportunity, however remote, which could prove beneficial. Our duty is to learn as much as we can about new and potentially helpful approaches to health challenges, especially diseases like ALS.