"Geron Corp. said it was cleared by U.S. regulators to proceed with the first human test of an embryonic stem-cell therapy, aimed at patients with spinal-cord injuries. The shares rose 17 percent....
Read more"Geron Corp. said it was cleared by U.S. regulators to proceed with the first human test of an embryonic stem-cell therapy, aimed at patients with spinal-cord injuries. The shares rose 17 percent.
The Food and Drug Administration lifted a clinical hold on the study imposed last August when the company revealed that mice used in experimental work had developed cysts, Geron said in a statement. The company may start recruiting patients with new spinal cord injuries in about one month, said Thomas Okarma, Geron’s president and chief executive officer, in a telephone interview today.
The FDA’s action will allow the company to proceed with a long-awaited milestone -- the first authorized clinical trial in the world using stem cells derived from human embryos. The approval comes after almost a year of Geron’s testing and genetic analysis to resolve FDA questions, and paves the way for future trials. "
excerpt from an article written by Rob Waters and Molly Peterson