The following two articles provide an excellent overview of the state
of stem cell and olfactory ensheathing glial cell therapies in Europe,
China, and Russia. The current state of affairs in Russia is that
stem cell therapy is illegal, you may or may not even be getting stem
cells when you receive "therapy," and there is no evidence the therapy
is safe or effective.
The work in China on spinal cord regeneration of Huang Hongyun of
Chaoyang Hospitalis at least being identified as research, but it
appears that the reporting is well below standards that would be
acceptable in Western nations or among scientists in general. It is
far from clear that the therapy is safe or effective.
The European research on spinal cord regeneration is much closer to
normal scientific standards, although there are some questions about
it. The media has also overhyped the results considerably. There is
a lack of evidence that the procedure is safe or effective. Carlos
Lima, from the Egaz Moniz Hospital in Lisbon, has treated some
patients. Almudena Ramón-Cueto of the Universidad Autónoma de Madrid
in Spain and Geoffrey Raisman at the National Institute of Medical
Research in London are also pursuing clinical trials. Another
researcher in Brisbane, Australia, Alan Mackay-Sim, is engaging in
exploratory clinical trials.
"The exciting question was whether the glial cells might encourage
regrowth of spinal-cord neurons. Several scientists jumped on it,
conspicuously Almudena Ramón-Cueto of the Universidad Autónoma de
Madrid in Spain and Geoffrey Raisman at the National Institute of
Medical Research in London."
"The pressure is now intense to get to clinical trials. The United
States alone has on the order of 200,000 patients with spinal-cord
injuries. (Their plight was dramatized by Christopher Reeve, the
quadriplegic Superman and spinal-cord campaigner, who died on October
10, 2004.) Raisman is pushing toward trials, as is Ramón-Cueto. In
June 2003, Raisman told the BBC, ?My guess is we are probably two to
three years away. It could be less.? A group in Brisbane, Australia,
led by Alan Mackay-Sim, has duplicated the rat experiments with
ensheathing cells and is at the stage of exploratory clinical trials;
Carlos Lima, from the Egaz Moniz Hospital in Lisbon, has treated a
small number of patients. Yet extreme caution is obviously necessary:
the procedure raises great scientific, medical, regulatory, and
ethical problems. In a recent telephone conversation, Doucette
emphasized repeatedly that the basic physiology is still not
understood. 'Just putting the cells in and saying, ?Oh, great, we?ve
got some functional recovery,? and then moving on to the next step, to
me isn?t satisfactory. I want to know how it happened. Why. And how
you can control it,' he said. He went on: 'My view is that I think
we?re probably five, ten years away. In terms of being at a stage
where I?m confident we know enough about what?s going on.'"
"Huang reported his work?announcing that he had now given
fetal-olfactory-ensheathing-cell transplants to more than 300
patients, including a number of Americans and other Westerners. Some
patients, Huang said, showed improvements two or three days after the
operation, although all experimental evidence said that nerves could
not regrow that fast. He had tried no placebos; his assessments were
unblinded and were thought rudimentary. He reported no adverse
consequences, although with so many cases that was implausible.
Follow-up was minimal and never conducted more than a few months after
the procedure. The ethical risks were obvious and considerable."
"That same day, public broadcasting stations aired an hour-long
program called ?Miracle Cell,? part of the starry-eyed series
Innovation. Though it didn?t mention Huang, the program presented
Lima?s work in Lisbon, enthusiastically overstating the progress his
patients had made, and gave Raisman in London a platform from which to
announce his plans for clinical trials. ?Miracle Cell? repeatedly
confused fetal olfactory ensheathing glial cells with stem cells."
"As the questioning went on, problems with Huang?s methodology seemed
to emerge, chiefly the lack of rigorous pre- and postoperative
evaluation of patients? functioning, the lack of controls, and, above
all, the total absence of follow-up beyond a few months."
"The science of Dr. Huang Hongyun raises to our awareness this deep
tension over standards of evidence and the ethics of clinical
practice."
"The Problematical Dr. Huang Hongyun" By Horace Freeland Judson,
Technology Review (January 2005)
http://www.technologyreview.com/articles/05/01/issue/judson0105.asp?p=1
"Scientists warn that while stem cells are still being researched in
laboratories, treatment by clinics claiming to use stem cells may cost
patients their health and fortunes. Moreover, they say, even though
it?s illegal, enforcement is lax and no one knows if the injections
patients are getting contain stem cells."
"'Stem cell therapy' craze spreads in Russia" The Associated Press,
MSNBC News (March 14, 2005) http://www.msnbc.msn.com/id/7129297/
Sincerely,
Wonko |
