The US Food and Drug Administration (FDA) has approved California based Geron Corporation to carry out the world’s first human embryonic stem cell (hESC)-based clinical. Geron will test the stem cells on eight to 10 patients with severe spinal cord injuries.
The trials are set to begin at seven medical centers aims to mainly determine the safety of the cells in human subjects. Researchers will also look for any signs that the therapy restored sensation or movement.
“This is obviously an extraordinarily exciting event,” Geron chief executive Thomas B. Okarma said. “It marks the dawn of a new era in medical therapeutics. This approach is one that reaches beyond pills and scalpels to achieve a new level of healing.”
President Barack Obama is set to lift restrictions on federal funding for such research imposed by former President George W. Bush in 2001. Geron’s work had not been restricted by the Bush administration policy. The cells being used by the company were derived from leftover embryos at fertility clinics before 2001.