Getting Cured Fast
Embryonic stem cell research has been given a boost with the approval of the first-time test of a stem cell medical treatment on human beings. The proponents of this type of research are hopeful that the Obama administration will soon lift the Bush administration's controversial ban on federal funding for embryonic stem cell research and accelerated work relating to the development of cures for cancer, heart disease, diabetes, Alzheimer's, and Parkinson's.
FDA Approval
On January 23, 2009, the Food and Drug Administration (FDA) gave approval to begin human tests on the use of stem cells for the repair of spinal cord injuries. The first test will begin during the summer and will be performed on 8-10 participants with spinal cord injuries below the neck. This is according to Thomas Okarma, the CEO and president of Geron Corp., in Menlo Park, Ca. which is responsible for developing the treatment. Injections of the therapeutic agent will be administered from 7 days to 2 weeks after the injury is incurred.
This first phase of testing is focused on establishing the safety of stem cell therapy. However, researchers are eager to see if the injected cells can close the breach in a severed spinal cord as was seen in stem cell studies on mice. Because embryonic stem cells can metamorphose into any kind of human tissue cells, researchers are sold on their therapeutic potential. The Geron researchers will also be evaluating the trial participants for renewed function and feeling in the bowels, bladder, and legs. If the trial passes muster for safety, Geron is hoping to expand the trials to include participants who have suffered the more common cervical spinal cord injuries, which are responsible for paralysis in the four limbs.
Just A Coincidence
Okarma denies that the timing of the FDA approval is anything other than a coincidence, despite the fact that it was given only three days after President Obama took office. "We have no evidence that there was any political shadow over this process," said Okarma.
The embryonic stem cells to be used by Geron derive from lines created prior to the 2001 Bush administration's ban on federal funding for embryonic stem cell research. The controversy which led to the ban comes from the fact that the cells are derived from unutilized human embryos intended for in vitro fertilization. The FDA's approval of these first human trials brings optimism that Obama's administration or Congress will move to lift the ban, which researchers claim has impeded their ability to move faster in creating possible cures for some serious diseases.
Scientists aim to use stem cells in three ways:
1) To create a multitude of live human cells on which new drugs can be tested in a laboratory setting.
2) As the equivalent of a patch kit, in which cells—heart muscle or spinal cord, for instance—can be injected into injured parts of the body.
3) For the creation of transplants which can replace body parts.
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