The first-in-human clinical trial testing the safety of neural stem cell transplantation in patients with spinal cord injuries has been expanded to add four more qualifying participants with chronic cervical injuries involving C5-C7 vertebrae.
The trial, launched in 2014, is a collaboration between researchers at UC San Diego School of Medicine, the Sanford Stem Cell Clinical Center at UC San Diego Health, and Maryland-based biotechnology company Neuralstem.
Researchers recommend that patients considering their involvement in the trial should live within a 500-mile radius of San Diego due to the trial’s intensive follow-up schedule.
The primary objective is to determine the safety and toxicity of treatment, which involves a surgical intervention with six stem cell injections and a follow-up period of 60 months. Researchers will be using a line of human stem cells approved by the FDA for human trials in patients with chronic traumatic spinal injuries. The stem cells have previously been tested for safety in patients with amyotrophic lateral sclerosis, explains a media release from University of California San Diego Health.
“The ultimate goal is development of an effective treatment for paralyzing spinal cord injuries,” says Joseph Ciacci, MD, principal investigator and neurosurgeon at UC San Diego Health, in the release. “The immediate goal is to determine whether injecting these neural stem cells into the spines of patients with injuries is safe.”
For more information regarding the trial or to become a participant, contact Ciacci’s research office at [email protected] or 619-471-3698.
[Source(s): University of California San Diego Health, Newswise]
