The first clinical trials of treating people with embryonic stem cells have started in the U.S. The trials were green-lighted after Food and Drug Administration licensed the Geron, a biotechnology company in Silicon Valley in California, to use them in treating patients having spinal cord injuries.
The first spinal patient is undergoing treatment at Shepherd Center in Atlanta, Georgia,– hospital and research center specializing in rehabilitation of spinal patients and patients with brain injuries. This is one among seven centers in the U.S. which can participate in such trials.
Main purpose of the trials is to test tolerability and safety of treating spinal cord injuries with embryonic stem cell based products. The treatment applies progenitors of oligodendrocytes derived from embryonic stem cells. Product that is being tested is called GRNOPC1. It is assumed that patients undergoing trials should be treated within two weeks after the injury.
Oligodendrocytes are nervous tissue cells which perform several important functions. One of them is production of myelin which wraps around axons of nerve cells to enable them conduct nerve impulses. In addition, oligodendrocytes produce substances necessary to support the nerve cell maintenance. The destruction of oligodendrocytes because of spinal cord injury leads to myelin loss, and conduction of nerve impulses is disrupted, which leads to paralysis in many spinal patients.
Tests of GRNOPC1 on animals with acute spinal cord injuries demonstrated that the progenitors of oligodendrocytes contributed to the remyelination and growth of nerves, and accordingly, to the restoration of lost function, when the drug was administered 7 days after injury.
Nevertheless, more tests are needed to clarify how safe and effective the therapy is for people.