Jonathan D. Glass, MD, site investigator at Emory University, recently presented long-term follow-up data regarding the Phase I trial testing of Neuralstem Inc’s NSI-566 human neural stem cells in the treatment of amyotrophic lateral sclerosis (ALS). A Neuralstem news release notes that the presentation took place at the Annual Symposium on ALS of the Foundation Andre-Delambre, in Montreal, Canada, and was not open to the public. The presentation addressed data up to approximately 1,200 days post stem cell treatment.
According to the release, Glass stated that patients in the last safety cohort (n=3), who received treatments in both the lumbar and the cervical region with the highest number of cells per injection, all exhibited significant slowing of the progression of the disease. One patient exhibited functional improvement from pre-treatment baseline, which is reportedly maintained to present day. The other two patients are maintaining the same level of functionality as they had at the baseline for more than 3 years since the stem cell treatment, the release notes.
Karl Johe, PhD, Neuralstem chairman and chief scientific officer, calls the long-term follow up data “very encouraging.”
“In Phase I, patients 10, 11, and 12 each received 10 lumbar and five cervical injections, of 100,000 cells each, which was far below the safe maximal dose. Even so, the data shows a significant slowing of the disease progression for over 3 years. If replicated on a larger scale, this could represent meaningful improvement in quality of life, and lifespan, compared to untreated patients,” Johe says.
Johe adds that in the Phase II dose escalation trial, researchers successfully reached the maximal dose planned. This dose was comprised of 20 lumbar and 20 cervical injections of 400,000 cells each, more than ten times the number of stem cells delivered in the highest dose cohort of the Phase I trial, Johe explains.
Glass echoes Johe’s positive sentiments about the trial’s progress, pointing out that it “has provided data on the safety of multiple injections and multiple transplantation surgeries in ALS patients, as well as the long- term survival of the transplanted cells in the human spinal cord. This provides a strong foundation for moving ahead with more definitive trials focused on the potential therapeutic efficacy of spinal cord transplantation of neural stem cells for ALS.”
The release reports that Neuralstem’s NSI-566 spinal cord-derived neural stem cell therapy Phase II clinical trials for ALS concluded final surgeries in July 2014.
Source: Neuralstem Inc