Posted on 04/22/2005 1:33:12 PM PDT by neverdem
MADISON, Wis. (AP) -- A University of Wisconsin-Madison researcher said he would ask federal regulators Friday to approve the first clinical trial injecting special stem cells into the spinal cords of people with the degenerative nerve ailment called Lou Gehrig's disease.
The trial would test whether a technique anatomy professor Clive Svendsen has pioneered on rats afflicted with the disease is safe to use on people. If successful, Svendsen said a much larger clinical trial aimed at treating the disease could be under way in two or three years.
About 30,000 Americans currently have the disease, which gradually kills brain cells that control muscle movement. The disease, formally known as amyotrophic lateral sclerosis, or ALS, typically can lead to death in a few years and has virtually no treatment.
Svendsen and his colleagues are asking the U.S. Food and Drug Administration for approval to bypass testing the technique on primates, typically the next step after rats, and to go straight to humans. The trial would involve five ALS patients treated by neurosurgeons at the Cleveland Clinic.
The trial would build on research Svendsen published this week in the journal Human Gene Therapy, which found that injecting certain types of stem cells into the spinal cords of rats could help stave off the disease and potentially prolong their lives.
Svendsen and his colleagues said the study was the first to show that the stem cells carrying a protein that fights ALS could flourish after being injected into their bodies.
The ALS Association, which is spending millions of dollars to fund Svendsen and other researchers rushing to find a cure, called the research encouraging.
''It is so exciting to see how rapidly ideas are moving from the laboratory into potential clinical applications through strong collaborations with leading investigators,'' the association's science director, Lucie Bruijn, said in a statement Thursday.
While noting the promise of his research, Svendsen sought to play down expectations, saying a cure of the debilitating disease was still years away.
''We're not going to cure ALS in the first clinical trial,'' Svendsen said Thursday at a forum on bioethics in Madison. ''We're going to tell the patients that as well.''
The research does not involve human embryonic stem cells, the blank-slate cells derived from human embryos that can be molded into any type of tissue cell in the body.
Researchers are instead using neural progenitor cells in fetal brain tissue, which are in the early stages of brain development. Those cells -- derived from miscarried fetuses -- are obtained through the National Institutes of Health.
Svendsen's research team first created stem cells that pumped the disease-fighting protein, and then had to find the exact location in the rat's spinal cord to inject them to fight ALS. The latter step took months of trial and error but may help surgeons deliver the treatment to humans.
Svendsen acknowledged the clinical trial proposal was risky. If the research on humans fails or is deemed unsafe, it could set back the field for years.
But he said waiting to unleash a potential cure for the lethal disease was unacceptable and the research has been safe so far.
''We're hoping the FDA doesn't require a lot more animal work,'' he said.
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On the Net:
University of Wisconsin-Madison: http://www.wisc.edu
ALS Association: http://www.alsa.org
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Researchers are instead using neural progenitor cells in fetal brain tissue, which are in the early stages of brain development. Those cells -- derived from miscarried fetuses -- are obtained through the National Institutes of Health.
It's quite possible that these are really cells from aborted babies - miscarried fetuses would not likely be a good source for cells unless the miscarriage was caused by premature labor in the mother, and a healthy child died very shortly before, or just after the delivery. That is possible, and I hope it is, and if so bless those bereaved mothers who give their children's bodies up for a good cause.
Abortionists have the supply lines for baby body parts well laid out.
Mrs VS
Why would anyone at the National Institutes of Health do that? Spontaneous abortions happen all the time. If it were true, and it came to the light of day, there could be hell to pay career-wise.
In spontaneous abortions, there is very often something genetically wrong with the baby, and the baby very frequently dies some days, even several weeks, before the actual miscarriage occurs, or a D&C is performed. Only a small minority of miscarriages could yield usable tissue, and the scientists at the NIH don't seem to be trying any harder than any other scientists to obtain morally licit stemcells.
Mrs VS
Full Text HD-92-10 HUMAN FETAL TISSUE BANKS
NIH GUIDE, Volume 21, Number 22, June 12, 1992
RFA: HD-92-10
P.T. 0780020, 0705035, 0780030
Keywords:
National Institute of Child Health and Human Development
Letter of Intent Receipt Date: June 26, 1992
Application Receipt Date: August 3, 1992
PURPOSE
The purpose of this Request for Applications (RFA) is to support the initial research necessary to provide and assess the quality and quantity of human fetal tissues available solely from spontaneous abortions and ectopic pregnancies to serve as sources for transplantation therapy; to develop and test effective methods for human fetal tissue banks to use in obtaining, testing, culturing, and preserving those tissues and transporting them for transplantation; and to gain information on the epidemiology and mechanisms of early pregnancy loss.
I don't know the source of the stem cells other than what the story says.
If it is accurate, and the source is miscarriages donated for research, I can appreciate the mother's generosity, and respect her desire for some good to come from a personal tragedy.
I still believe that umbilical cord harvesting and adult stem cell research is the path to success, and that fetal stem cell research is wrong, both morally and practically.
It is an attempt to legitimize abortion and use the excuse of potential miracle cures to camouflage the needless killing of unborn babies .
That is good to see. Of course it was written thirteen years ago - I hope it is a continuing effort.
Mrs VS
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