California Supporting Embryonic Stem Cell Clinical Trial

(NIH)

The California Institute for Regenerative Medicine (CIRM) awarded a $25 million grant to support the first FDA-approved clinical trial based on human embryonic stem cells. The award to Geron Corporation in Menlo Park, California, will support the company’s early phase trial, already underway, for people with spinal cord injury.

CIRM, the state’s stem cell agency, says this is the first time it has funded a human clinical trial testing a stem cell-derived therapy. The agency was created by the passage of proposition 71 in 2004. The CIRM funding of $25 million requires matching support from  Geron as the Phase 1 trial proceeds.

Geron is currently conducting a phase 1 clinical trial of GRNOPC1, Geron’s cell therapy containing cells derived from human embryonic stem cells. The trial tests GRNOPC1 in patients with neurologically complete injuries in the thoracic region of the spinal cord. In the current first group of patients, a dose of 2 million cells is being administered to assess safety.

Pending the demonstration of safety, says Geron, clinical testing will be expanded to patients with injuries to the cervical region and to patients with incomplete injuries, as well as to assess escalating doses of GRNOPC1. The CIRM award is expected to support funding of clinical trial costs, supporting non-clinical studies, analytical development, and the manufacture of cells to be used in the clinical trials.

Read more: Clinical Trial of Stem Cell Therapy Underway

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