|Katie Sharify talks about participating in Geron's spinal cord injury trial|
Katie had a great story to tell about what it’s like to be a patient in a stem cell clinical trial. She had very little understanding of the science before her injury and had very little time to get as informed as possible before making a decision about whether or not to participate. She needed to get herself educated in just six days and she needed to educate her parents (who speak little English) while also adapting to life in a wheelchair.
The trial Katie was considering was in phase I, which means that the scientists were primarily testing whether the cells were going to be safe. This is always the first phase of testing any new drug or therapy, before testing higher doses in more people in a phase II trial.
Katie told me that it would be impossible not to hope that a trial would help her, but that by the time she made the decision to participate she knew she was doing it to further science, not necessarily to further her own recovery. She told the audience, “I was part of something that was bigger than me, and bigger than all of you.”
Geron’s was the first clinical trial to test a therapy based on embryonic stem cells. Soon after Katie enrolled in the trial, Geron stopped the trial for business reasons though the company remained committed to following the five patients who had already participated for the full 15 years. We wrote a Q&A about that decision here. Geron returned CIRM's loan that supported the trial with interest.
Ever since Geron’s decision to terminate the trial there has been speculation about other companies buying those embryonic stem cell programs and picking up the trial where it left off, and about CIRM’s role in a continued trial. Recently, Geron entered into a nonbinding agreement to transfer their embryonic stem cell programs to BioTime, Inc. (here is the Geron press release). There are still a lot of unknowns in that agreement, but if it goes through it could mean that more people with recent spinal cord injuries have a chance to make a decision like Katie’s.
BioTime already has one $4 million award from CIRM (you can read a summary of that award on our website). They would need to apply for a loan if they want CIRM to financially support the continued trial.
11/28/12: A video of this conversation is now live: