Doctors in the U.S. have begun treating the first patient with embryonic stem cells as part of the first human study of the controversial treatment authorized by the government, the Geron Corp. announced on Oct. 11 .
The patient was enrolled at a spinal cord and brain injury rehabilitation hospital in Atlanta, Georgia, where Geron began clinical trials to assess the safety and tolerability of their GRNOPC1 human embryonic stem cells in treating spinal injuries.
"Initiating the GRNOPC1 clinical trial is a milestone for the field of human embryonic stem cell-based therapies," said Thomas Okarma, 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."
Copyright Agence France-Presse, 2010