First patient enrolled in landmark stem cell trial

[News_Editor]

First patient enrolled in landmark stem cell trial

2010-10-11 19:49:45 GMT+7 (ICT)

MENLO PARK, CALIFORNIA (BNO NEWS) -- Geron Corp. on Monday announced the enrollment of the first patient in the company's clinical trial of human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells, GRNOPC1.

Few details about the start of the landmark clinical trial were released because they are being kept confidential. Geron is the first company to have a license from the U.S. Food and Drug Administration (FDA) to use the controversial cells to treat people.

The primary objective of Phase I study is to assess the safety and tolerability of GRNOPC1 in patients with complete American Spinal Injury Association (ASIA) Impairment Scale grade A thoracic spinal cord injuries. Participants in the study must be newly injured and receive GRNOPC1 within 14 days of the injury.

The patient was enrolled at Shepherd Center, a 132-bed spinal cord and brain injury rehabilitation hospital and clinical research center in Atlanta. Shepherd Center is one of seven potential sites in the United States that may enroll patients in the clinical trial.

"Initiating the GRNOPC1 clinical trial is a milestone for the field of human embryonic stem cell-based therapies," said Thomas B. Okarma, Ph.D., M.D., Geron's president and CEO. "When we started working with hESCs in 1999, many predicted that it would be a number of decades before a cell therapy would be approved for human clinical trials. This accomplishment results from extensive research and development and a succession of inventive steps to enable production of cGMP 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."

Donald Peck Leslie, M.D., medical director at Shepherd Center, said he was pleased to see their patients participating in the trial. "Our medical staff will evaluate the patients' progress as part of this study," he said. "We look forward to participating in clinical trials that may help people with spinal cord injury."

David Apple, M.D., Shepherd Center's medical director emeritus and principal investigator of the trial at Shepherd Center, 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. Shepherd Center is an ideal place to conduct this study because of our clinical expertise and the volume of patients referred here for rehabilitation care."

In addition to Shepherd Center, Northwestern Medicine in Chicago is also open for patient enrollment.

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