A first-in-human trial has been expanded to add four more qualifying participants with chronic cervical injuries involving C5-C7 vertebrae. Launched in 2014 with the initial phase I study, this first-in-human clinical trial is evaluating the safety of neural stem cell transplantation in patients with chronic spinal cord injuries.
The trial is a collaboration between researchers at UC San Diego School of Medicine, the Sanford Stem Cell Clinical Center at UC San Diego Health (San Diego, USA) and Neuralstem, a Maryland, USA-based biotechnology company.
The primary objective of the trial is to determine the safety and toxicity of a treatment involving 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 US Food and Drug Administration 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.
“The ultimate goal is development of an effective treatment for paralyzing spinal cord injuries,” says Joseph Ciacci, principal investigator and neurosurgeon at UC San Diego Health. “The immediate goal is to determine whether injecting these neural stem cells into the spines of patients with injuries is safe.”