Le April 8 (Bloomberg) -- Embryonic stem cells may someday cure disease, reverse paralysis or restore memory. Scientists worry they also may trigger benign tumors, and even cancer.
Geron Corp. and Advanced Cell Technology Inc. plan this year to begin the first human tests of therapies created with stem cells extracted from human embryos. The U.S. Food and Drug Administration, which may soon approve the studies, is asking the companies to closely monitor whether the therapies can spur non-cancerous growths, as has been seen in animal tests.
The first human studies, by Menlo Park, California-based Geron, may start as soon as this summer in patients partly or wholly paralyzed. The FDA is convening a special public session Scientists discovered how to obtain stem cells from human embryos and cultivate them in the laboratory in 1998, according to the U.S. National Institutes of Health. Since then, researchers have begun coaxing the cells to grow into different tissue types that can help patients repair diseased organs.
Advanced Cell is testing therapies derived from embryonic cells for treating eye diseases, a market it estimates at $28 billion. The company is aiming at curing diseases including macular degeneration, an illness that weakens the part of the eye responsible for sharp vision and affects about 15 percent of people over the age of 75, according to the NIH.
Novocell Inc., a closely held company based in San Diego, is creating insulin-producing cells for diabetics. Geron is attempting to treat spinal cord injuries by turning stem cells into a type of nerve cell that insulates the spinal cord. At the FDA session this week, the three companies will discuss ways to monitor safety so clinical trials can proceed, they said.
The San Francisco-based stem cell institute was established after California voters approved Proposition 71 in 2004. The measure authorized the state to sell $3 billion in bonds to fund research on stem cells, especially those derived from embryos, over a 10-year period.
Early clinical trials with stem cells provide different challenges than typical drug trials, the FDA staff wrote in documents filed last week on its Web site.
To contact the reporter on this story: Elizabeth Lopatto in New York at email@example.com. Last Updated: April 8, 2008 16:22 EDT