BrainStorm Cell Therapeutics Inc. develops adult stem cell technologies and therapeutics for the treatment of neurodegenerative diseases. The company today announced that the Israeli Ministry of Health (MOH) has granted clearance for a phase I/II clinical trial using BrainStorm’s autologous NurOwn™ stem cell therapy in patients with Lou Gehrig’s disease.
The clearance is an impressive milestone for BrainStorm, as it is the first company to receive clearance from the MOH for a differentiated stem cell-based therapy in Israel.
“The Israeli Ministry of Health’s clearance of our NurOwn clinical trial is one of BrainStorm’s most significant accomplishments to date,” Chaim Lebovits, president of BrainStorm stated in the press release. “We believe that our specific differentiated stem cells derived from a patient’s own bone marrow could represent a new treatment paradigm for patients with [Lou Gehrig’s disease] and other neurological disorders.”
The phase I/II clinical trial will begin after validation of sterility tests and the completion of patient screening, and will be conducted in cooperation with the world-renowned Hadassah Medical Center, with the initial phase designed to establish the safety of NurOwn. After this is demonstrated, the company said it will expand the trial to assess efficacy.
Robert H. Brown Jr., M.D. Ph.D., professor and chair of neurology at the University of Massachusetts Medical School, noted the significant, positive implications that the safety and efficacy of NurOwn would bring to the healthcare field.
“We are very excited by this new approach to develop neuronal supporting cells; the hope is that these cells will be neuroprotective and clinically beneficial in several neurological diseases, such as [Lou Gherig’s disease] and Parkinson’s Disease,” Dr. Brown stated. “Successful slowing of these diseases using these neural-supporting mesenchymal cells would have a profound impact on the field. If safe and effective, this new therapy could become a treatment option for thousands of patients.”
For more information visit www.brainstorm-cell.com
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