Geron GRNOPC1 Spinal Cord Injury Trial Update – November 2011

UPDATE:  THE GERON EMBRYONIC STEM CELL TRIAL FOR SPINAL CORD INJURY HAS BEEN STOPPED DUE TO FINANCIAL REASONS.

The Phase 1 trial for Spinal Cord Injury using an embryonic stem cell therapy procedure GRNOPC1 is a little over a year in duration, with the first candidate completing a record of no safety issues since the trial began.  The last candidate enrolled in the trial, completed their 30-day follow up with no safety issues.

So far, “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.  This drug 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.”

The number one goal of this trial is to show safety for the therapy.  So far it has done that.  According to the video below, Hans Keirstead indicates, the trial will need to enroll all 12 people into the trial, with a 2-year completion.  This trial won’t be complete until 2014 at a minimum.

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.”