Dr. Wise Young's scientific work, passionate commitment and advocacy have driven the field of SCI restorative research for the past two decades. He is usually slow to criticize peers but minces no words when speaking of India's Geeta Shroff or Beike Biotechnology in Shenzhing.
"I think Beike is a scam," he says. "I just don't think they're doing anything that could be construed as a clinical trial, and they're charging a lot of money for a procedure that probably has no effect." He says the company is huge and treats two to five people per day. "They have probably done thousands of procedures, and they're trying to recruit people in the U.S. and in Europe. Their website has blogs and testimonials from those they treated, but by their own admission, they choose only the positive stories to display."
Beike's promotional methodology is clearly disturbing to Young. He says they charge foreigners much more than they charge people from China and they encourage people to return every three or four months to get repeated injections at $20,000 to $30,000 apiece. "This is just not only unethical," he says, "it's fraudulent."
Young's assertions are based in science. "These guys are not using HLA [human leukocyte antigen] matched cells. They have this theory that UCB cells don't have to be matched in order for them to engraft. This is total nonsense, 25 years of studies have shown that you have to match UCB cells or else they don't engraft. They say they're doing a clinical trial but they do no follow-up. All they have are testimonials. And finally, they say it's 100 percent safe and 80 percent effective. This is directly out of their website — the typical language and approach that is being used to take advantage of people."
And Geeta Shroff?
"She's also a scam. She has no background in stem cells, has never done anything in stem cells, never published anything in stem cells, and all of a sudden she comes out with something that she claims are human embryonic stem cells. They've not allowed anyone to look at these things, they've provided no evidence that these are human embryonic stem cells. And what is also not being published is there are multiple lawsuits against her by people who claim that she has done nothing, and there are a number of investigations. Geeta Shroff herself would take patients and tell them that she's going to cure them — even before she sees them and examines them."
Lack of scientific data on SCI cure/restoration procedures in China and other countries points to the need for rigorous human clinical trials. Partly to gather data, as well as raise standards of neurological examination, evaluation and clinical trial design in China, Wise Young has organized an SCI trials network involving 25 facilities, 15 of which are now Good Clinical Practices qualified. Xi Shan Hospital, where Hongyun Huang offers his OEG implantation procedure, is one of 10 facilities in the network that have not yet met the GCP standard. Huang's procedure is not part of the network's trials.
Young emphasizes the network is a nonprofit research project and is in no way related to "Stem Cells China" or Beike Biotechnology. "The China SCI Network is a consortium of 25 leading SCI Centers in China and Taiwan," he says. "These are the top universities, top medical centers, all who are taking care of large numbers of people with SCI."
Are the trials open to Americans?
"Of course Americans can go to China, but we would expect them to go through all the examinations over there. We're not going to have people get their treatment in China, then come back to the U.S. and not get follow-up. I've been saying to everybody, 'Look, instead of going over to China, let's do [additional] clinical trials in the U.S."
Telltale Signs of Scams
• Incredible claims ("100 percent safe and 80 percent effective") and claims of effectiveness for many conditions.
• Claims that a therapy is one-of-a-kind, a secret or proprietary cell or process.
• Being charged for clearly experimental therapies that have not yet been proven to be safe and effective.
• So-called "clinical trials" that do not collect data or examine you carefully before or after the treatment.
• Doctors or groups that do not publish their results in legitimate scientific or medical journals. — Thanks to www.carecure.com and Dr. Wise Young
Presently, however, it will take two or more years to secure NIH funding for U.S. clinical trials. Young says the best hope now is to support the Christopher and Dana Reeve Paralysis Act, which would provide about $100 million over three years for research to reverse paralysis. "Right now we're very close," says Young. "The House already passed the bill, and the Senate would have considered it in December, except an Oklahoma senator put a secret hold on the bill and has refused to lift it."
A second hope is for individual states to push for SCI restoration research, but well-conceived clinical trials run about $50 million each. In the meantime, the China SCI Network functions like a national clinic/laboratory. The trials are based on a 2004 paper published by Young's colleagues at Hong Kong University, which reported that lithium not only stimulates regeneration in the spinal cords of rats, but also causes stem cells to proliferate. "Lithium also causes certain types of stem cells to produce a lot of growth factors, particularly the neurotrophins."
Additionally, the Hong Kong team found that UCB cells transplanted into the spinal cord encourage axon growth and do not cause tumors. "What we hypothesized," says Young, "was that these UCB cells would be important to test as a potential source that could bridge the injury site. And it was attractive that these cells poured out neurotrophins when we gave the animals lithium."
Young says two of the three requirements that he considers crucial to the combination therapies of the future have already been fulfilled — a way to bridge the injury site, and sustained growth factor support. "The third component, which we need to add," he says, "is a drug that locks growth inhibitors. Within a very short time, we hope to provide proof that we can actually do a combination therapy that addresses all the major obstacles to regeneration in the spinal cord." The design of the trials includes chronic as well as acute and sub-acute SCIs.
"China is a remarkable place to do SCI research," says Young. "In the United States, there is somewhere around 34 new SCI cases per year/per million. In China it's 64 per year/per million.
Since China has 4.5 times the U.S. population, that means 90,000 new SCIs annually, or nine times more per year than in the United States.
But numbers alone do not sum up the need. "These people are absolutely desperate," Young says. "They are more desperate than people in the United States simply because the care is not there. I'm absolutely certain that people are dying of UTIs and all the problems that people with SCI have.
"A lot of people didn't understand that the reason I started China SCI Network is to bring some hope to the people in China; that they need therapies, too; that China SCI Net is for China. And that we should do a USA Network or North American SCI Net for the United States," he says.
"It does not make sense for us to go overseas for therapies. It's bad for the clinical trials, and it's bad for the United States."
Wise Young Explains China SCI Network Clinical Trials
By Tim Gilmer
In 2004 Dr. Wise Young and colleagues at Hong Kong University demonstrated that, in rats, lithium stimulates regeneration of the spinal cord and causes stem cells to proliferate. The first in a series of clinical trials, completed in Hong Kong in December 2007, assessed the safety and feasibility of giving lithium for six weeks to 20 human patients with SCI. "It basically showed that the treatment is safe," says Young.
A second double-blind phase II trial, started at the China Rehabilitation Research Center in Beijing, randomized 40 patients to lithium or placebo, to see whether or not the lithium is producing any neurological benefit.
Before this, all 25 centers in the China SCI Network began participating in an observational trial where each center collects data on 20 patients according to protocol, examining the patients in exactly the same way. Since 25 centers are involved and some collect data from more than 20 patients, about 600 patients will have been examined at least three times and followed for a period of one year. "These patients will become the candidates for the phase III trial that will start probably at the end of 2008," says Young. "These are all chronic [long term] SCI patients. Our initial approach is toward chronic patients."
The network also has completed a cell transplant phase I trial involving 30 patients with acute and early SCI. "We operated on the patients, but did not transplant any cells," says Young. [In phase I] we did decompression of the spinal cords of patients between two days and 69 days after injury. We opened up the dura, we exposed the spinal cord, and we also cut into the spinal cord itself — if we thought there was necrotic or broken-down tissue in the middle — to wash out the dead tissue. These patients actually did very well with this procedure. Many of the patients walked, and we just submitted this for publication."
The next study will involve 40 patients and transplantation of umbilical cord blood cells. "These cells will contain most of the stem cells in umbilical cord blood. Blood is damaging to the spinal cord," says Young, "so you have to isolate them, and we're isolating one particular faction of cells called mononuclear cells." These cells will be transplanted into the 40 patients, with half getting a single bolus dose of methylprednisolone. "We have seen in animal studies that a single bolus dose of methylprednisolone — which is the standard therapy for acute SCI — given intravenously, markedly improved the survival of transplanted cells, and we want to see whether this is true in humans.
"So we're going to do what we call a phase two umbilical cord blood mononuclear cell transplant. Once we have completed all these things, the phase I and the phase II, then we're going to take 400 of the patients that have been examined in the observational study, and all of these patients will get umbilical cord blood mononuclear cells — half of them will get lithium, the other half will not. It's a randomized trial to assess the effect of lithium on the umbilical cord blood cells."
What will be learned by this series of studies?
"We now know lithium is safe," says Young. "By the end of the trials we will know whether umbilical cord blood mononuclear cell transplants into the spinal cord are safe. We will also be able to know whether or not it improves function, compared to before the surgery. If we see improved function, we still may not necessarily know that this is directly from the transplant itself. On the other hand, if we see that lithium improves the effect, it must be that lithium plus the cell transplants is better than the transplant by itself," he says. "This, on its own, would be sufficient for us to recommend that the lithium plus umbilical cord blood cells be used for treatment of SCI.
"On the other hand, if we find that umbilical cord blood mononuclear cells don't do anything for people with SCI — they don't improve or even get worse — we would be able to say definitively that this procedure should not be used."