The final patient has reportedly been treated in Neuralstem Inc’s Phase II trial, using NSI-566 spinal cord-derived neural stem cells in the treatment of amyotrophic lateral sclerosis (ALS). A news release issued by Neuralstem states that the multicenter Phase II trial treated a total of 15 ambulatory patients in five different dosing cohorts.
The first 12 patients, the release says, received injections in the cervical region of the spinal cord only, in escalating doses ranging from five injections of 200,000 cells per injection, to 20 injections of 400,000 cells each. The trial’s final three patients received both cervical and lumbar injections, totaling out to 40 injections of 400,000 cells each, or 16 million cells transplanted.
In the Phase I trial, the first three patients received the maximum 15 injections of 100,000 cells each, for a total of 1.5 million cells. The release notes that the trial is slated to continue until 6 months postsurgery, at which point researchers will evaluate the data.
Principal investigator Eva Feldman, MD, PhD, director of the A. Alfred Taubman Medical Research Institute and director of Research of the ALS Clinic at the University of Michigan Health System, adds, “We look forward to seeing what the data tell us about safety and efficacy of this approach. It is also worth noting that we will have completed this Phase II trial within a year, roughly. I would like to thank Dr Parag Patil, and my collaborators at Emory, Drs John Glass and Nick Boulis, and at Mass General, Drs Merit Cudkowicz and Larry Borges, for helping us reach this goal.”
Jonathan D. Glass, MD, director of the Emory ALS Center, designates the Phase II completion as a “major milestone” that demonstrates patients can tolerate the transplantation of high doses of cells and multiple spinal cord injections.
“From both a clinical and scientific perspective, I think we are now ready to move forward toward a true therapeutic trial to test the efficacy of this surgical approach for slowing the course of ALS,” Glass says.
Karl Johe, PhD, Neuralstem Chairman of the Board and Chief Scientific Officer, expresses his thanks in the release to the doctors and medical staff, patients, and their families who made the trial possible, stating that with the “landmark” trial, “we hope to establish the dose that is both safe and which may be optimal for treatment. We are excited about the collection and analysis of the final data and look forward to advancing to our next trial.”
[Source: Neuralstem Inc]