Mount Sinai Medical Center, internationally acclaimed for its excellence in research, patient care, education in multiple sclerosis and a range of medical specialties, was recruited by clinical sponsor BrainStorm Cell Therapeutics, Inc (BCLI) as a clinical trial site for the sponsor’s Phase II study for administration of NurOwn® (autologous MSC-NTF cells) in participants with progressive Multiple Sclerosis.
A Phase II open-label, multicenter study of repeated intrathecal administration of NurOwn® in participants with progressive Multiple Sclerosis, the study will involve 20 participants and runs till September, 2020. It is sponsored by BrainStorm Cell Therapeutics, Inc. Fred Lublin, MD an internationally recognized Multiple Sclerosis expert, will serve as the Principal Investigator.
What is NurOwn?
NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.
Who is BrainStorm Cell Therapeutics?
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. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. Dr. Lublin and several leading MS experts previously served as consultants to Brainstorm in the initial study conception and design. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company’s website.
Call to Action: Those interested in this advanced cell therapy for neurodegenerative disorders, such as MS, may want to monitor this study.Source: Yahoo! Finance