Treatment with NG-01 — an approach that uses patients’ own mesenchymal stem cells (MSCs) — safely and effectively delayed disease progression in people with active, progressive multiple sclerosis (MS), according to final data from a Phase 2 clinical trial.
Delivering these cells directly into the cerebrospinal fluid (CSF) — the fluid that bathes the brain and spinal cord — resulted in greater benefits in all evaluated disease measures, than when cells were injected into the bloodstream.
“The treatment was well tolerated and the trial met all of its primary [goals],” Dimitrios Karussis, MD, PhD, the trial’s principal investigator and the director of Hadassah’s MS Center, said in a press release.
“The patients’ improvement was in many cases quite remarkable and included regain of motor function and noticeable effects on their cognitive abilities,” Karussis said.
Tal Gilat, NeuroGenesis’ CEO, said they are “extremely pleased to witness the significant positive effect of our NG-01 cells” in a “chronic, debilitating disease with no satisfactory treatment to improve or reverse established disability.”
The results were reported in the study, “Beneficial effects of autologous mesenchymal stem cell transplantation in active progressive multiple sclerosis,” published in the journal Brain.
These promising findings — already shared with the U.S. Food and Drug Administration — are planned for further validation in a larger Phase 3 trial.
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