Science. Communication. Community.
As a scientist, I support the promising possibilities of stem cell research—but as a daughter, I worry about the inherent risks of participating in clinical trials.
Last week, my father pointed out an article in the local newspaper about clinical trials using stem cells for patients with spinal cord injuries. A year ago, it would have evoked a passing interest; I think stem cell research holds a lot of promise, and I’m always interested to hear about innovative therapeutics that have made it to the point of human trials. Seven months ago, though, my dad was paralyzed from the waist down, and everything changed. Now these trials hit very close to home, and my dad wasn’t sharing it with me just because he thought I might have an intellectual interest. He saw them as a possible way to walk again, and he was asking me to help him get enrolled.
The article discussed two trials that share the same premise: inject stem cells into the patient’s spine, with the hope that they will proliferate and heal the neural connections severed by the spinal cord injury. Only one trial, however, is currently ongoing. Starting in 2011, StemCells Inc. has been recruiting patients in Switzerland and Canada for its treatment, which uses tissue-derived, “adult” stem cells, as opposed to the more controversial embryonic stem cells, and earlier this month they announced that they have received FDA authorization to expand the trial to the United States.
The other trial, which had begun in 2010, used embryonic stem cells, but Geron, the company running the trial, shut it down just over a year later for financial reasons. At that point, four or five patients had been injected with the cells (sources vary regarding the exact number).
Ending the trial for reasons other than the patients’ wellbeing raises serious ethical concerns. The enrolled patients agreed to put themselves at risk, likely hoping both for personal benefit and to further the knowledge about the general efficacy of stem cell treatments; ending the trial undermines that difficult decision. At least the patients were not completely hung out to dry; Geron says that it has continued to monitor the patients, and the ClinicalTrials.gov entry for the trial was last updated in January 2013, suggesting that the trial has not been completely abandoned. Nonetheless, learning this history hasn’t done much to alleviate my hesitations about my father participating in such a study.
In the end, the decision has been made for us, at least for now; my dad is outside the age range for the StemCells trial. It’s possible, though, that Geron’s stem cells may be getting a new lease on life. They were recently acquired by Asterias Biotherapeutics, who report that they hope to reactivate the spinal cord injury trial in 2014, subject to FDA authorization. The original Geron trial only enrolled patients within two weeks of their injury, but we don’t know yet what the inclusion criteria may be under Asterias. Who knows; maybe by the time a trial rolls around that my dad qualifies for, I’ll be ready to help him test the possibilities of regenerative medicine.