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FDA lifts hold on stem-cell trial

The US Food and Drug Administration has lifted its hold on Geron's phase I study of GRNOPC1 – the first-ever human embryonic stem cell-based therapy

The US Food and Drug Administration (FDA) has lifted its hold on a clinical trial of the first-ever human embryonic stem cell-based therapy, allowing Geron's phase I study of GRNOPC1 in patients with acute spinal cord injury to proceed.

The FDA instructed the company to put the study on hold in August of last year after animal data showed higher frequency of small cysts in the injury site in the spinal cord of animals injected with GRNOPC1 than had been observed in other preclinical studies.

The federal agency lifted the hold based on Geron's completion of an additional confirmatory animal study to test new markers and assays.

The primary endpoint of the multi-centre clinical trial is the safety of the investigational therapy, which aims to restore spinal cord function through the injection of hESC-derived oligodendrocyte progenitor cells into the lesion site of the injured spinal cord.

However, the study also includes a number of secondary endpoints related to efficacy, including improvement in neuromuscular control or sensation in the trunk or lower extremities.

Once safety has been established, Geron hopes to win approval to increase the dose it is permitted to study and to test the therapy in several different types of spinal cord injury.

Geron is also working to develop GRNOPC1 in other degenerative central nervous system (CNS) disorders, including Alzheimer's disease, multiple sclerosis and Canavan disease, a fatal neurological disorder that strikes infants and young children.

3rd August 2010

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