(This is the sidebar, actual article below)
Telltale Signs of Scams
Beware of:
• 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• Doctors or groups that do not publish their results in legitimate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.
---
Dr. Wise Young on Stem Cells
By Tim Gilmer
March 2008
Dr. Wise Young
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,
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."
http://www.newmobil
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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