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First human embryonic stem cell trial

Human embryonic stem cells are to be used in patients for the first time in a US clinical trial

Human embryonic stem cells are to be used in patients for the first time in a US clinical trial.

Geron Corporation, the US biotech behind the trial, announced that human embryonic stem cell-derived oligodendrocyte progenitor cells (GRNOPC1) will be used as an investigational treatment for patients with spinal cord injuries after receiving approval from the US Food and Drug Administration (FDA).

"Initiating the GRNOPC1 clinical trial is a milestone for the field of human embryonic stem cell-based therapies," said Geron president and CEO, Dr Thomas B Okarma.

"This accomplishment results from extensive research and development and a succession of inventive steps to enable production of cGMP (cyclic guanosine monophosphate) master cell banks, scalable manufacture of differentiated cell product, and preclinical studies in vitro and in animal models of spinal cord injury, leading to concurrence by the FDA to initiate the clinical trial."

Participants involved in the trial must be newly injured and receive stem cell treatment within two weeks of injury. The first patient was enrolled on Monday, October 11, at the Shepherd Center – a spinal cord and neuromuscular rehabilitation hospital and research centre based in Georgia, US.

There are six other centres in the US where patients can participate in the trial.

Dr David Apple, the Shepherd Center's medical director emeritus and principal investigator of the trial, said: "This clinical trial represents another step forward in Shepherd Center's involvement in an attempt to find a cure for paralysis in people with spinal cord injury.”

In the trial, GRNOPC1 will be injected into the site of the spinal cord injury. The aim of the treatment is to replace the naturally occurring oligodendrocyte progenitor cells lost in injury with the stem cells found in GRNOPC1.

Oligodendrocyte cells produce myelin, an insulating layer of cell membrane that enables the functioning of nerves in the brain and spinal cord. The loss of myelin can cause paralysis in patients.

Stem cell treatment has shown positive results in studies on animal models, demonstrating the stimulation of nerve growth in acute spinal cord injury. Further studies have also shown significant improvement in the movement of animals following an injection seven days after receiving spinal cord injury.

According to Geron, around 12,000 people a year in the US receive spinal cord injuries, with common causes including car accidents and sports injuries.

12th October 2010

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