The FDA approves the commencement of a Phase 2 double-blinded clinical trial for Brainstorm Cell Therapeutics' (BCLI +2.1%) NurOwn mesenchymal stem cells for the treatment of ALS patients.
The trial will begin at Mass General Hospital in Boston and the UMass Memorial Hospital in Worchester after the respective IRB approvals. The Mayo Clinic will also participate.
Dana-Farber Cancer Institute's Connell O-Reilly Cell Manipulation Core Facility will manufacture the NurOwn cells for the two MA sites.
The trial will evaluate the safety and efficacy of the transplantation of Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (NurOwn) in 48 ALS patients. The cells will be administered in combined intramuscular and intrathecal injections.
The primary endpoint is safety and tolerability as defined by the number of patients with adverse events. Secondary endpoints will measure the changes in ALS Functional Rating Scale and Slow Vital Capacity.