Geron Corp (stock symbol GERN) said today that the U.S. Food and Drug Administration has given the company approval for it to start trials for what it says is the world's first study of a human embryonic stem cell-based therapy for people. Geron said it will begin a Phase I multicenter trial designed to establish the safety of its treatment, currently referred to as "GRNOPC1," in patients with complete Grade A subacute thoracic spinal cord injuries.The trials will allow Geron to inject 8 to 10 patients with cells derived from embryonic cells. The recipients will be paraplegics. They will receive a single injection within two weeks of them suffering this particular injury. Research is expected to occur in a handful of medical centers across the nation.
The trials are said to be a milestone and will delve into the benefits and limitations of using embryonic stem cells on spinal cord injuries.
Embryonic stem cells can develop into any cell of the body, and scientists have long hoped to harness them for creating replacement tissues to treat a variety of diseases. But research has been controversial because embryos must be destroyed to obtain them.
The granting of this clinical trial may be a indication of things to come. President Barack Obama has promised to relax the Bush administration's restrictions on federal financing for such research. In fact, Obama has mentioned that science needs to be put back where it should be.
Based on animal testing using embryonic stem cells, researchers are hoping to inject the cells in the spine. As they mature, they expect it to repair damaged nerves and provide substances that nerves need to function and grow.
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