New embryonic stem cell experiment
Government regulators have given the go-ahead to a second study that will for the first time carefully test a treatment created using human embryonic stem cells in people, according to the company sponsoring the experiment.
The Food and Drug Administration approved a request by Advanced Cell Technology Inc. of Marlborough, Mass., to inject cells created from human embryonic stem cells into the eyes of 12 patients suffering from advanced cases of a disease that causes blindness.
Stargardt's Macular Dystrophy, which is one of the most common forms of juvenile macular blindness, progressively destroys vision, usually beginning in childhood. It is currently incurable.
The study will involve injecting 50,000 to 200,000 cells known as retinal pigmented epithelial cells in the hopes that they will replace those ravaged by the disease. Studies in rats found the cells helped prevent further vision loss and even restored some sight. While the study is designed primarily to test the safety of the treatment, researchers will looks for signs of improvement in the patients' vision. The company hopes the approach will work for many conditions, including the leading cause of blindness among the elderly.
"I think this marks the beginning of a new era for stem cell research," Robert Lanza, the company's chief scientific officer, wrote in an email. "After a decade of intense controversy, the field is finally ready to prove itself--and to actually start helping patients suffering from a range of horrific diseases. It also shows the new readiness of the FDA to work with researchers to move exciting new stem cell therapies out of the laboratory and into the clinic."
The study will be conducted at the Casey Eye Institute in Portland, Ore., and University of Massachusetts Memorial Medical Center in Worcester, and the University of Medicine & Dentistry of New Jersey in Newark.
The approval follows a decision by the FDA in July to authorize the first carefully designed study testing a therapy created using human embryonic stem cells in humans. That study, being sponsored by Geron Corp. of Menlo Park, Calif., will involve 10 patients partially paralyzed by a spinal cord injury in the previous one to two weeks. Patients are receiving millions of "oligodendrocyte progenitor cells" created from embryonic stem cells in the hopes the cells will form a restorative coating around the damaged spinal cord. In tests in hundreds of rats, partially paralyzed animals regained movement. The first patient to get the therapy as part of the trial was treated in October in Atlanta and is now being monitored closely.
The studies are being welcomed by many stem cell researchers, patients and advocacy groups. But those with moral objections to any research using cells from human embryos object to the study. And the tests are worrying some proponents of the research. Some argue that the experiments are premature. Others question whether they are ethical. Many fear that the trials risk disaster for the field if anything goes wrong.
The studies are beginning as the future of federal funding for human embryonic stem cell remains uncertain. A federal judge ruled in August that the Obama administration's new, more permissive guidelines violated a federal law barring taxypayer money from being used for research that involves the destruction of human embryos. The administration appealed, and an appeals court panel in September allowed the funding to continue while the case is argued in court.
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