BrainStorm Cell Therapeutics Inc., has announced that the Cleveland Clinic is the first U.S. clinical site contracted for a planned Phase 2 open-label, multicenter study of repeated intrathecal administration of autologous mesenchymal stem cells secreting neurotrophic factors (MSC-NTF) in participants with progressive Multiple Sclerosis (MS). The Phase 2 study (NCT03799718) will enroll progressive MS patients [Expanded Disability Status Scale (EDSS) 3.0-6.5] based on 2017 revised McDonald Criteria.
BrainStorm Cell Therapeutics Inc., founded in 2004, based in New York City, is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement.
MS is a chronic neuroinflammatory and neurodegenerative disorder that affects the brain and spinal cord. MS affects approximately 1 million individuals in the U.S. and 2.5 million individuals worldwide. Approximately half of affected individuals will eventually develop a progressive disease, which may lead to increasing levels of motor, visual, and cognitive functional impairment and disability.
Cleveland Clinic is currently ranked as the No. 2 hospital in the country, according to U.S. News & World Report (2017-2018). The Mellen Center for Multiple Sclerosis Treatment and Research at Cleveland Clinic is one of the largest and most comprehensive programs for MS care and clinical research worldwide, managing over 8,000 patients and over 21,000 total visits annually.
“We are very excited to announce The Mellen Center for MS Treatment and Research at Cleveland Clinic as the first contracted U.S. clinical site for this very important Phase 2 progressive MS study that we plan to initiate in early 2019,” … “This is a crucial step forward toward rapidly enrolling a Phase 2 study to evaluate this innovative autologous cell therapy approach using our NurOwn® technology platform in progressive MS patients.” – Chaim Lebovits, president and CEO of BrainStorm
“Progressive MS treatment options are limited and do not directly address unmet need.” … “This phase 2 clinical trial is an important part of our commitment to bring a new treatment modality and hope to MS patients” – Ralph Kern MD MHSc, COO and CMO of BrainStorm