A first-in-human phase I clinical trial in which neural stem cells were transplanted into chronic spinal cord injury patients produced improved motor and sensory function in three of four subjects with no adverse effects, according to results published in Cell Stem Cell.
Here are five things to know:
1. Four trial participants with one- to two-year-old T2-T12 spinal cord injuries underwent spinal instrumentation removal, laminectomy and durotomy, followed by six midline bilateral stereotactic injections of NSI-566 cells.
2. NSI-566 cells are a human spinal cord-derived neural stem cell line developed by Neuralstem. Each injection contained 1.2 million neural stem cells.
3. There have been no serious adverse events 18 to 27 months post-grafting. Analysis of motor and sensory function and electrophysiology results showed improvement in three participants.
4. According to principal investigator and UC San Diego Health neurosurgeon Joseph Ciacci, MD, the study primarily aimed to prove treatment safety and tolerability. He claims further exploration of NSI-566 cells in dose escalation studies is warranted.
5. A second clinical trial is in development and will focus on participants with cervical spinal cord injuries.
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