A clinical trial of an adult stem cell therapy to treat Amyotrophic Lateral Sclerosis (ALS) was launched at the Hadassah University Medical Center in June. The treatment, known as NurOwn™, is a product of BrainStorm Cell Therapeutics, the first company to receive approval from the Israeli Ministry of Health for a differentiated stem cell-based therapy.
The Phase I/II clinical trial will be conducted by a joint team headed by Principal Investigator Prof. Dimitrios Karussis, M.D., Ph.D., Director of Hadassah’s Center for Multiple Sclerosis in the Department of Neurology, and a scientific team from BrainStorm. The initial phase of the study is designed to establish the safety of NurOwn™; later, the trial will be expanded to assess efficacy.
Patients will be transplanted with stem cells derived from their own bone marrow and treated with Brainstorm’s NurOwn™ stem cell technology. The cells are capable of self-renewal as well as differentiation into many cell types. The trial will include a total of 24 patients, 12 in an advanced stage of the disease and 12 in an early stage. The patients will be examined at regular intervals and followed for 6 months post-transplantation.
“We are very excited to have reached the human clinical trial stage with our stem cell therapy,” relates Dr. Adrian Harel, acting Chief Executive Officer of BrainStorm. “The trial represents a significant step forward in our goal of using stem cells with neuro-restoration capabilities to treat ALS.” He adds: “We expect to begin treating patients in the coming weeks and look forward to working with the Hadassah Medical Center and its renowned staff.”
“We at Hadassah are delighted to collaborate with BrainStorm on these important clinical trials in ALS, the first with this type of stem cells,” Prof. Karussis said. “We believe that together we may achieve a breakthrough for the treatment of people suffering from ALS.”