“It doesn’t seem controversial to me,” said Sharify. “If there is something in the medical field that could possibly help people, why wouldn’t you pursue it?”
Lea Suzuki/San Francisco Chronicle/Polaris Katie Sharify (right), who received stem cell therapy before the study she was part of was cancelled, talks with her sister, Julie Sharify (left), in the day room at Santa Clara Valley Medical Center on Dec. 13.
Many physicians and researchers agree. But Sharify has more than an academic interest in the topic: On Nov. 2, she was in a devastating car accident that left her paralyzed from the waist down. On Nov. 16, she became the fifth person in the country to receive a human embryonic-stem-cell-derived therapy aimed at testing whether the cells are safe to use in humans.
The procedure was performed by Stanford neurosurgeon Gary Steinberg, MD, PhD at the Rehabilitation Trauma Center at the Santa Clara Valley Medical Center. Steinberg is the Bernard and Ronni Lacroute-William Randolph Hearst Professor in Neurosurgery and Neurosciences at Stanford and the principal investigator of the Stanford/SCVMC portion of the nationwide, multicenter trial.
In a strange twist of fate, the trial in which Sharify had enrolled, which was sponsored by Menlo Park-based Geron Corp., was discontinued two days before her treatment.
“It was very unfortunate,” said Sharify. “At that point I felt very let down and didn’t know if I wanted to go forward with the procedure. But then I decided that five patients were still better than four, and that I could still have some sort of an impact.”
Researchers had initially planned to enroll eight to 10 patients in the phase-1 trial. The first patient was treated at the Shepherd Center in Atlanta in October 2010; the first patient in the Stanford/SCVMC portion of the trial was treated Sept. 17. Sharify is the second. The five patients who have received the treatment will be monitored for the next 15 years, according to the company, which terminated the trial because of financial considerations and plans to concentrate on developing new cancer therapies.
The Geron trial was the first to implant cells derived from human embryonic stem cells into human patients. For the spinal cord injury trial, researchers at Geron and UC-Irvine developed a way to coax human embryonic stem cells to become a mixture of cells that include oligodendrocyte precursors. Oligodendrocytes are cells in the brain and the central nervous system that wrap nerve cells with an insulating material called myelin. This myelin sheath is necessary for the transmission of the electric signals along the spinal cord that trigger muscles to move, and relay our sense of touch and temperature. Damage to this sheath caused by trauma is a common cause of paralysis. As a trial participant, Sharify received an injection of about 2 million specialized cells called GRNOPC1 directly to the injured area of her spinal cord.
Doctors don’t expect the cells to help Sharify walk again; phase-1 trials are designed simply to test whether a particular therapy is safe. But her willingness to speak up for human embryonic stem cell research could be important in a field that can be both politically and fiscally tenuous.
“I believe Katie is a very courageous and incredibly optimistic individual,” said Steinberg. “I greatly admire her positive attitude and the way she has responded to her accident by becoming a passionate advocate for developing novel strategies to treat spinal-cord-injured patients, including stem cell therapy. She is an inspiration to all of us.”
Sharify was released from Valley Medical Center on Dec. 14, although she will be returning there from her family’s home in Pleasanton for follow-up visits and rehabilitation sessions.
“I really want to be an advocate,” said Sharify. “Up until this point, I had no passion in my life. I had changed my major in college a few times, but was not very enthusiastic about any of them. For once in my life, I’m very passionate about something. This is something to live for.”