US biotech company Geron Corp has announced plans to launch the world's first study of embryonic stem cell treatment of spinal cord injury. The much awaited project was cleared by the FDA this week.
The study involves injecting eight to 10 patients with cells derived from embryonic cells, says Dr Thomas Okarma, president and CEO of Geron Corp.
The patients will be paraplegics who can't walk but are able to use their arms. They will receive a single injection in the spine at the site of the injury.
The study will test the safety of the procedure, but signs of improvement like return of sensation or movement in the legs will also be tracked.
Whatever the outcome, the study, which marks a new chapter in one of the most contentious fields of medical research, and will likely open up new treatment options for patients with debilitating medical conditions.
While the medical researchers are now looking forward to using the therapy to treat a host of conditions, there is a lot of hope of the spinal cord injury community riding on the study.
Embryonic stem cells are precursors of differentiated cells of body tissues. They can develop into any cell of the body and hold out promise for creating replacement tissues to treat a variety of diseases. But research in the field has been controversial and halting, because embryos have to be destroyed in the process of harvesting the cells.
Studies on animals have led researchers to believe that once they are injected into the body, the cells will mature and repair the damage to the insulation around the damaged nerves.
Apart from the safety aspect, investigators will also be on the look out for signs of improvement in the patient according to the company. The objective, the company says, is provide some level of ability that can be improved by physical therapy they add.
The study which will track each patient for at least a year will involve anti-rejection drug treatment for about two months.
Geron Corp has spent upwards of $100 million on research into stem cells. The company was founded in 1992 and does not have any therapies presently on the market.
The company is considered a leader in embryonic stem cell development with claims on several key stem cell technologies. The company helped finance research at the University of Wisconsin where human embryonic stem cells were first isolated in 1998. The company retains exclusive rights on several of those cell types.