With the first-ever human test of a medical treatment based on embryonic stem cells gaining federal approval, researchers are optimistic that President Obama will soon lift a controversial Bush-administration ban on federal funding for embryonic stem cell research and speed work developing treatments for diabetes, heart disease, cancer, Parkinson's, and Alzheimer's.
The Food and Drug Administration today approved human tests of stem cells to repair spinal cord injuries. The first test will involve eight to 10 people with spinal cord injuries below the neck and will start sometime this summer, according to Thomas Okarma, president and CEO of Geron Corp. of Menlo Park, Ca., which developed the stem cell treatment. Patients will be injected seven to 14 days after being injured.
Although this Phase 1 test is intended just to test the safety of the stem cell treatment, the researchers will be looking closely to see if the injected cells bridge the gap in a severed spinal cord, as stem cells have done in mouse studies. Embryonic stem cells have the ability to turn into any type of human tissue cell, which is why researchers are so excited about their potential. The Geron researchers also will assess whether the patients gain any return of sensation, bowel or bladder function, or movement in their legs. "That would be a very exciting finding," Okarma said. If this trial does well, the company expects to expand it to include patients with cervical spinal cord injuries, which are much more common and cause paralysis in all four limbs.