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.”
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.”