Wed, Oct 13, 2010 - Page 7 News List

US starts first human embryonic stem cell test

AFP, WASHINGTON

US doctors have begun the first tests of human embryonic stem cells in patients, treating a man with spinal cord injuries in a landmark trial of the controversial process, the Geron Corp said on Monday.

The patient began the pioneering treatment on Friday with an injection of the biotech company’s human embryonic stem cells, as part of a clinical trial that aims to test safety and efficacy toward regaining sensation and movement.

The treatment took place at the Shepherd Center in Atlanta, Georgia, a spokeswoman for the hospital said, declining to give further details due to patient privacy concerns.

The Phase I trial is expected to involve around 10 patients. Participants in the human trials must be severely injured and start treatment with Geron’s product, GRNOPC1, seven to 14 days after sustaining their injury.

Patients will be given a single injection of 2 million of Geron’s GRNOPC1 cells in the trial.

Those taking part will be followed up for one year to monitor safety and also to see if they have regained any sensory function or movement in their lower extremities.

If the initial group of subjects shows no negative side-effects, Geron plans to seek FDA approval to extend the study to increase the dose of GRNOPC1 and to include patients with “as broad a range of severe spinal cord-injured patients as medically appropriate.”

The ultimate goal for GRNOPC1 is to inject it directly into the spinal cord lesions where it would, the firm hopes, prompt damaged nerve cells to regrow, enabling patients to eventually recover feeling and movement.

Geron began working with human embryonic stem cells in 1999.

Geron president and chief executive Thomas Okarma said in a statement that the start of the clinical trial was “a milestone for the field of human embryonic stem cell-based therapies.”

Geron got clearance in January last year from the US Food and Drug Administration to conduct human trials of GRNOPC1. About six weeks later, US President Barack Obama reversed a ban on federal funding for research on human embryonic stem cells, which had been imposed by former president George W. Bush.

However, the clinical trials of GRNOPC1 remained on hold for more than a year while the US courts wrangled about whether lifting the ban on embryonic stem cell research was legal.

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