There were no adverse events related to worsening of MS disease and no clinically significant changes in safety lab results/vital signs. In contrast, matched CLIMB registry participants showed declines in function on the LCLA and MSFC. Treated participants had mean improvements from baseline of 3.3 points in the LCLA binocular (2.5% contrast), 3.8 points on the SDMT, and 0.18 points in MSFC. In all participants treated with MSC-NTF, functional improvements were seen in LCLA, SDMT and MS Functional Composite (MSFC). "There are both promising biological and preliminary clinical signals of a treatment effect that will require confirmation in a randomized trial." "We were pleased that the study's initial results showed efficacy in patients with progressive MS," said Jeffrey Cohen, MD, Hazel Prior Hostetler endowed chair professor, Cleveland Clinic Lerner College of Medicine, director, Experimental Therapeutics, Mellen Center for MS Treatment and Research, and the paper's lead author. Outcome measures included the timed 25-foot walk speed (T25FW), 9-hole peg test (9HPT), multiple sclerosis walking scale (MSWS), symbol digit modality test (SDMT), and low contrast letter acuity (LCLA) as shown in the Table: Functional measures for these individuals were compared with 48 case-matched participants in the Comprehensive Longitudinal Investigation of Multiple Sclerosis (CLIMB) registry. In the phase 2 trial ( NCT03799718) 20 participants, mean age 47 and mean Expanded Disability Status Scale (EDSS) score of 5.4 at screening, were enrolled, and 17 had 3 scheduled treatments with MSC-NTF. As published in Multiple Sclerosis, off-the-shelf growth factor-secreting stem cell (MSC-NTF) (NurOwn BrainStorm Cell Therapeutics, New York, NY) treatment of people with progressive multiple sclerosis (MS) improved function compared with case-matched individuals in a registry study.
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