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Old 02-22-2019, 01:40 PM
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Default MSC stem cell therapy clinical trial launching for progressive MS

BrainStorm Announces First Contracted U.S. Clinical Site for Phase 2 Progressive MS Study
Phase 2 Open-Label Trial of Autologous MSC-NTF Cell Therapy (NurOwn®) in Progressive MS Patients will Begin Enrollment in Early 2019

February 22, 2019 07:30 ET | Source: BrainStorm Cell Therapeutics Inc.

NEW YORK and CLEVELAND, Feb. 22, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today Cleveland Clinic as the first U.S. clinical site contracted for a planned Phase 2 open-label, multicenter study of repeated intrathecal administration of autologous MSC-NTF cells 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.

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.

“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,” said Chaim Lebovits, president and CEO of BrainStorm. “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.”

“Progressive MS treatment options are limited and do not directly address unmet need”, said Ralph Kern MD MHSc, COO and CMO of BrainStorm, “This phase 2 clinical trial is an important part of our commitment to bring a new treatment modality and hope to MS patients”.

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.

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Dave Bexfield
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