First-in-Human Stem Cell Clinical Trial for Spinal Injury Expands

Testing to add more participants with chronic cervical spinal cord injuries

Article ID: 672368

Released: 3-Apr-2017 4:05 PM EDT

Source Newsroom: University of California San Diego Health

  • Credit: UC San Diego Health

    Joseph Ciacci, MD

Newswise — 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 and Neuralstem, a Maryland-based biotechnology company.

The trial has been expanded to add four more qualifying participants with chronic cervical injuries involving C5-C7 vertebrae. Due to the intensive follow-up schedule, participants should consider their geographical distance from San Diego. Living within a 500-mile radius of San Diego is recommended. 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.

“The ultimate goal is development of an effective treatment for paralyzing spinal cord injuries,” said Joseph Ciacci, MD, 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.”

For more information on the trial or participation, contact Ciacci’s research office at nksidhu@ucsd.edu or 619-471-3698.

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