¦ January 23, 2009
Great News!
U.S. Government approves first stem cell study for spinal cord injury

California based biotech company Geron plans to start the world’s first study of a spinal cord injury treatment based on human embryonic stem cells.  The initial study is expected to begin this summer. 

According to their website, www.geron.com, patients eligible for the Phase I trial must have documented evidence of functionally complete spinal cord injury with a neurological level of T3 to T10 spinal segments and agree to have GRNOPC1 injected into the lesion sites between seven and 14 days after injury. Geron has selected up to seven U.S. medical centers as candidates to participate in this study and in planned protocol extensions. The sites will be identified as they come online and are ready to enroll subjects into the study.

Although the initial study is aimed at testing the safety of the procedure, doctors will also look for signs of improvement like return of sensation or movement in the legs.  Prominent spinal cord injury researchers have expressed their enthusiasm for this trial and their hope of a promising future for stem cell-based treatments.

Whatever its outcome, the study will mark a new chapter in the history of embryonic stem cell research in the United States.  President Barack Obama has promised to relax the Bush administration’s restrictions on federal financing for such research.  However, the U.S. Food and Drug Administration’s granting permission for the new study predates his inauguration and involves stem cells that were eligible for federal funding under Bush.  According to Geron, no federal money was used to develop this experimental treatment or to pay for the human study.

In a statement on the company’s website, Geron’s president and CEO Thomas Okarma, Ph.D., M.D. said, “The FDA's clearance of our GRNOPC1 IND is one of Geron's most significant accomplishments to date.  This marks the beginning of what is potentially a new chapter in medical therapeutics - one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells. The ultimate goal for the use of GRNOPC1 is to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient's injured spinal cord."