The first trial is being done at the Shepherd Center, which Geron describes as a 132-bed spinal cord and brain injury rehabilitation hospital and research facility. Jane Sanders, a spokesperson for Shepherd, said the facility is not giving out details about the patient or the trial, nor is it granting interviews.
Anna Krassowska, director of investor and media relations at Geron, also said it will not release details of the patient other than to say he or she meets the FDA requirement that the patient must be newly injured within 14 days of the trial's commencement.
This first trial is focused on efficacy, meaning that it is trying to determine if the use of human stem cells is safe. A potential cure is not the purpose.
"What we're doing here is injecting live human cells that, based on the animal evidence to date, permanently regenerates the tissue into which we inject them, creating a healed environment," Geron Rpesident and CEO Dr. Thomas Okarma said.
Back in July, Geron and the FDA indicated that seven medical research facilities will be participating in the initial trials. ABC7 News confirmed at that time that Stanford University School of Medicine is one of the seven. Dr. Gary Steinberg, director of the Stanford Institute for Neuro-Innovation and Translational Neurosciences, said that its early trials will also be about safety.
Reaction to this landmark trial has been both positive and negative.
Roman Reed, who was injured in a football game and is partially paralyzed from a spinal cord injury, is excited about the trials getting underway.
This is such a day of joy and happiness; the day of a cure is literally going to come now because we have started this step with human clinical trials," Reed said.
Reed has been a major leader in promoting embryonic stem cell research in California and across the country. He was disappointed that a California institution was not the first to kick off the trial, but he is happy nonetheless to see the work underway.
Raymond Dennehy, professor of philosophy at the University of San Francisco, said Monday's news is "like an atomic bomb" going off. He is concerned that the Shepherd Center trial will be the first step toward custom genetics and "designer babies." He says the moral and ethical debate is not over, even though the door has opened to stem cell trials.
"You're talking about conducting experiments on human beings and that is really a direct assault on the right to life and the right to bodily integrity," Dennehy said.
The trials will begin slowly, for now, just one patient at a time. But in due time, there could be as many as seven medical institutions conducting these trials, including Stanford and Northwestern.
