Clinical Trials for ESCR Treatments Starting in 2008
One of the favorite arguments used "against" federal funding for ESCR is that "ESCR hasn’t led to a single cure yet". The catch 22 is that lack of research funds inevitably leads to lack of progress.
But luckily those who make their false claim are grossly wrong, as I know of at least three treatments that will be going to clinical trials in 2008. Two are for spinal cord injury and one is to treat blindness.
Ironically the first treatment uses cells from the 8 week stage of development that were obtained from elective abortion, but which are actually eligible for federal funding:
Fetal Tissue Transplantation Research
In contrast to the protracted debate over research on fetuses and embryos, research involving fetal tissue has been a mainstay of modern medicine, funded in large part with federal dollars without controversy. Dating back to the 1930s, scientists have used tissue from aborted fetuses as a means of understanding cell biology and as an important tool in the development of vaccines. The 1954 Nobel Prize for Medicine, for example, was awarded to American immunologists who developed the polio vaccine based on cultures of human fetal kidney cells.
Read for yourself about one of the spinal cord injury treatments:
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Researchers at the University of California, San Diego (UCSD) School of Medicine report that paralyzed rats were able to walk six weeks after receiving grafts of human spinal stem cells (hSSCs). The rats had been paralyzed due to the loss of blood flow to the spine.
This type of paraplegia (spinal cord ischemia) is a serious complication that occurs in 20 to 40 percent of patients undergoing the surgical process called aortic cross-clamping. When the surgeon works on the aorta to correct a potentially lethal aneurysm, blood flow from the heart must be temporarily blocked with a clamp.
If the blood flow is blocked for 30 minutes, specialized spinal cord neurons called spinal inhibitory neurons can die. This can lead to irreversible spasticity, rigidity, or loss of muscle control, in the lower limbs, even though the spinal cord is intact.
“We demonstrated that when damage has occurred due to a loss of blood flow to the spine’s neural cells, by grafting human neural stem cells directly into the spinal cord we can achieve a progressive recovery of motor function,” said Martin Marsala, M.D., UC San Diego professor of anesthesiology. “This could some day prove to be an effective treatment for patients suffering from the same kind of ischemia-induced paralysis.”
Marsala is currently testing the human stem cell therapy for safety and efficacy in other animal models, and hopes to move to clinical trials in humans by next year.
This research is different from previous research. “Other human stem cell transplants in the spinal cord have focused on repairing the myelin-forming cells,” said co-author Karl Johe, a researcher at Neuralstem, the company that manufactures the hSSCs used in the study. “In this study, we succeeded at reconstructing the neural circuitry, which had not been done before.”
The research is published in the June 29, 2007 issue of the journal Neuroscience.
Then there is the well-known company Geron which will be starting their human clinical trials in the US in 2008 also:
Geron’s lead therapy has already shown dramatic success in animal models. In 2005, Hans Keirstead, a neuroscientist at the University of California, Irvine, who developed the treatment with funding from Geron, published a paper showing that paralyzed rats injected with the cells were able to walk again.
In Geron’s therapy, embryonic stem cells are the starting ingredient rather than the treatment itself. The embryonic stems cells, which are potentially able to form any human cell type, are transformed into oligodendrocytes — a type of brain cell that wraps itself around neurons, forming a fatty insulation layer that allows electrical messages to be conducted throughout the nervous system. These cells are then injected into the site of the injury, coating neuronal projections that were damaged in the accident and restoring communication to the nervous system.
Because cells are living tissue and their behavior is somewhat unpredictable, trials of cell-based therapies are more complex than trials of conventional drugs. Scientists at Geron have spent years studying their lines of embryonic stem cells, figuring out the precise series of conditions needed to grow giant vats of embryonic stem cells and to transform them into pure populations of oligodendrocytes. The Geron researchers have also developed a way to reliably freeze and thaw the brain cells, so that they can be manufactured in a central location, and then shipped to the hospitals where they will be used. "You can use it off the shelf, just like a pill," says Thomas Okarma, Geron’s chief executive officer. …..
Plans for the trials are already underway. According to Okarma, researchers have almost finished the protocol for the experiments and are in discussions with spinal cord injury centers throughout the country that will run the actual tests.
Finally there are two companies including Geron that are working on impending clinical trials for ESC-derived retinal cells.
Scientists are taking the first major step in using stem cells to replace retinal cells lost to degenerative eye diseases such as macular degeneration and retinitis pigmentosa. According to findings published today, researchers at the University of Washington in Seattle can reliably make retinal cells from embryonic stem cells. The researchers are now implanting the cells into blind animals to see if the cells can restore vision.
"This work is the first step toward retinal reconstitution," says Stephen Rose, chief research officer at the Foundation Fighting Blindness, a nonprofit funding agency based in Owings Mills, MD.
According to a paper published today in the Proceedings of the National Academy of Sciences, the researchers can reliably generate retinal progenitor cells, which then have the ability to turn into any cell type in the retina, such as photoreceptors, retinal ganglion cells, or other cells. Preliminary results show that when the cells are transplanted into retinas either in a dish or in live animals, the cells migrate to different layers of the retina and begin to express proteins characteristic of the resident cells, including photoreceptors……
Other groups are also developing stem cell therapies for the retina. Advanced Cell Technology (ACT), a stem cell biotechnology company based in Alameda, CA, has developed a way to turn embryonic stem cells into pigment epithelial cells, another cell type lost in macular degeneration.
When implanted into the eyes of animal models, the cells protect against further degeneration of the photoreceptors and improve vision, says Robert Lanza, vice president of research and scientific development at ACT. The company plans to file for permission from the Food and Drug Administration to start human trials of the therapy by the end of next year, he says.

