You are hereOctober 18, 2010 | Pluripotent Stem Cells
First spinal cord injury patient enrolled for Geron stem cell trial
The first official clinical trial using stem cells to treat patients with spinal injury is now underway (also see ‘US give Geron Go-ahead for ESC Trial for Spinal Cord Injury’). The first patient to receive the trial treatment was enrolled on Monday at Shepherd Center in Atlanta, Georgia. Another 9 patients who have recently suffered spinal cord injuries will be enrolled from 6 other potential sites in the United States to be listed on the company’s website. Patients undergoing the trial treatment will receive transplants of hESC-derived oligodendrocyte progenitor cells within 14 days of the injury.
The ‘silicon valley’ based biotech company has spent $170m on research and development over the 11 years leading to the approval of this trial in humans. In animal models of acute spinal cord injury, transplantation of human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells (GRNOPC1) resulted in some regain of movement, but it is unknown whether similar success will be achieved in humans.
The FDA has given Geron the go-ahead amongst a backdrop of politics and controversy currently surrounding the use of stem cells in the United States. The approval of this trial represents a milestone in the development of this therapy to treat paralysis in humans. The trials will be conducted primarily to prove the safety of the procedure in humans and will involve years of rigorous testing.