Meet Katie Sharify. She was the fifth and final person to get injected with embryonic stem cells in the now-defunct Geron trial last year. The California Institute for Regenerative Medicine (CIRM – the stem cell funding agency) released a video
today of Katie telling the story of how she came to join the trial.
It’s a revealing look at an important topic: How do people make the pressure-packed decision to participate in a trial that may not help them? In her case, Katie decided, against the wishes of her parents, to get the cells -- not for herself, but in order to help the field of regenerative medicine. If you go into the trial for selfish reasons, she said, you will be disappointed. Anyway, a year later, after some moments of regret and second guessing, Katie says she made the right decision and would do it again. “It’s bigger than me,” she said.
Katie tells her story: She was 23 at the time she was spinal cord injured in an auto accident in Northern California. She also had a brain injury and so for the first week in intensive care, she was in a drugged-up haze. When she came to her senses, her parents, who do not speak English well, told her she was paralyzed but that she was going to be in a clinical trial that would cure her.
Her doctors had sized her up as a candidate for the Geron trial and had begun discussions with Katie’s parents. Once the medical team explained to Katie what stem cells were, and that she would be enrolled in a Phase I safety trial that would not in all likelihood lead to any recovery, she had to break this news to her parents; they immediately objected to any further participation.
Katie thought about it, did her own research, asked a million questions of Stephen McKenna, M.D., chief of the rehabilitation center at Santa Clara Valley Medical Center, where the surgery would take place. She wasn’t sure; would this prevent her body’s natural recovery from occurring? She was urged to understand the severity of her injury; any effect would be minimal for a person with a complete thoracic injury. Meanwhile, the clock was ticking. The Geron protocol stated that the cells had to go in within 14 days of injury.
Katie and McKenna poured over the informed consent forms with great detail. She knew the risks. She understood she would be signing on for 15 years of follow-up. She finally said yes. The deal was sealed after a reassuring meeting the surgeon who would do the transplant (Gary Steinberg from Stanford) and the fourth patient in the Geron trial (also from the Bay Area, treated two months earlier, with no side effects).
So hey, Katie Sharify. Thanks for being a pioneer and for being part of regenerative medical history. And there's encouraging news. It seems that your trial may not be the last word on these cells. On November 15, Geron signed a letter of intent
to license its stem cell program to another San Francisco area company, BioTime (formed by two ex-CEOs at Geron).
Let’s hope this science grows. Maybe this really will be bigger than you, Katie.