It has taken more than five years of graft, but at long last approval has been given for the first clinical trial using human embryonic stem cells (hESCs). These cells can develop into all tissues of the body.
of Menlo Park, California, received the green light from the US Food and Drug Administration this week to use cells derived from hESCs to treat people with acute spinal cord injuries.
Ten people will receive injections into the injury site of hESC-derived oligodendrocyte progenitor cells, which stimulate the growth of new and severed nerves and recoat damaged nerves with myelin. The hope is that the injections will help people recover function lost through injury, as seen in rodent studies in 2005.
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Geron first received permission to proceed in January last year, only for the FDA to withdraw it in August following studies showing that some animals developed benign cysts around the injection sites. Further animal studies led to the FDA鈥檚 change of heart.
, a professor of regenerative medicine at University College London, says that the approval is excellent news and 鈥渨ell overdue鈥�.
鈥淲e just don鈥檛 know how hESC therapies will behave in humans unless we actually administer them to patients in the course of a properly conducted clinical trial,鈥� says Mason. 鈥淲hen we look back in 25 years, putting the first embryonic stem cells into humans will prove as momentous as man鈥檚 first step on the moon.鈥�
