GRNOPC1 was delivered to 4 spinal cord injured patients at a dose of 2M cells without complications from either the cells or the surgical procedure itself, and without any negative effects on the spinal cord or neurological function of the patients to date.
- The only side-effects observed were due to the immunosuppressive drug tacrolimus, which is administered for the first two months after injection of GRNOPC1. There is no evidence to date of immune rejection of GRNOPC1, an allogeneic cell therapy, including after withdrawal of immunosuppressive drug.
Endpoints of the trial are safety and evaluation of neurological function, using standardized testing at specified time points to monitor sensory and lower extremity motor function.
- One patient in the trial has completed the Day 365 follow-up visit. The most recent patient to be enrolled in the clinical trial has completed the Day 30 follow-up.
The Bottom Line: Safety data to date from the trial has shown:
- No surgical complications during or after the procedures;
- No adverse events related to the injection procedures or to GRNOPC1;
- A few mild adverse events related to tacrolimus;
- No evidence of cavitation in the spinal cord at the injury sites on MRI;
- No unexpected neurological changes;
- No evidence of immune responses to GRNOPC1.