Biomed Middle East

US begins first trial with human embryonic stem cells

The patient began the pioneering treatment on Friday with an injection of the Geron Corporation’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 spokesman for the hospital said.

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 two 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.

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 of injured humans where it would, Geron 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.

Then, “many predicted that it would be a number of decades before a cell therapy would be approved for human clinical trials,” Thomas Okarma, Geron’s president and chief executive, said in a statement.

Mr Okarma described the start of the clinical trial as “a milestone for the field of human embryonic stem cell-based therapies.”

Telegraph UK

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