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U.S. Approves First Stem Cell Study for Spinal Injury |
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U.S. Approves First Stem Cell Study for Spinal Injury
By Rob Stein Washington Post Staff Writer
Friday, January 23, 2009; 10:20 AM
Federal regulators have approved the first experiment testing human embryonic stem cells on people, officials announced today.
The Food and Drug Administration authorized the Geron Corp. of Menlo Park, Calif., to test stem cells derived from human embryos on eight to 10 patients with severe spinal cord injuries. The study is aimed primarily at determining the safety of the cells in human subjects, but researchers also will examine the patients for any signs the therapy restored sensation or movement
"This is obviously an extraordinarily exciting event," Geron chief executive Thomas B. Okarma said in a statement. "It marks the dawn of a new era in medical therapeutics . . . one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of health replacement cells."
Although researchers have already begun testing embryonic cells derived from adults and fetuses in people, the study will mark the first government- approved use of those derived from embryos, which have been highly controversial because the process involves the destruction of the embryos.
President Obama is expected to lift a ban on federal funding for such research imposed by his predecessor. While the timing of the FDA approval led some to speculate that the two moves were related, Geron's work had not been restricted by the ban. The cells being used by the company were derived from leftover embryos at fertility clinics before the ban was implemented in 2001.
The approval of Geron's project, however, has been eagerly awaited by proponents of embryonic stem cell research. The FDA had delayed approval of Geron's application in May, saying the agency needed more information.
"This is what we've all been waiting for," said Robert Lanza of Advanced Cell Technology in Worcester, Mass., which plans to ask the FDA to approve another study using embryonic stem cells to treat blindness. "The field desperately needs a big clinical success. It's very important to show the naysayers that this is very real and hopefully it will start helping people."
Lanza, however, expressed concern about the impact of a failure.
"When you're the first the whole world's eyes are on you," he said. "We all have our fingers crossed that everything goes smoothly and nothing happens."
The Geron experiment will involve injecting the embryonic stem cells for seven to 14 days at seven medical centers in the United States, the company said.
Geron has coaxed stem cells in the laboratory to become cells known as oligodendrocytes. Once injected at the site of a spinal cord injury, the hope is the cells will help repair a sheath around the nerve cells known as myelin, restoring the ability of some nerve cells to carry signals and perhaps allow damaged nerve cells to regenerate.
The patients will received anti-rejection drugs for 46 days, after which they will be slowly weaned off the medication. The company submitted a series of laboratory studies and 24 tests involving animals that received more than 5 billion cells, which officials said showed no signs of problems such as tumor formation for up to a year, which is one concern about using embryonic stem cells.
"This is an exciting first step for Geron and for spinal cord injured patients whose lives may improve due to advances in medical research," Peter T. Wilderotter, president and chief executive of the Christopher & Dana Reeve Foundation, said in a statement. "There has been so much speculative and unsubstantiated information about the use of stem cells in spinal cord injury; it is important to study these cells in a rigorously designed clinical trial that is monitored by the FDA."
Human embryonic stem cells are believed capable of being turned into any type of tissue in the body, raising hopes they can be used to treat a host of diseases.
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