BrainStorm Cell Therapeutics announces peer reviewed publication of NurOwn's phase III study for ALS in Muscle and Nerve journal.
The paper is entitled "A Randomized Placebo-Controlled Phase III Study of Mesenchymal Stem Cells Induced to Secrete High Levels of Neurotrophic Factors in Amyotrophic Lateral Sclerosis."
Data from the paper are from a randomized, double-blind, placebo-controlled, Phase III trial evaluating the safety and efficacy of repeat doses of NurOwn (stem cell therapy) in study participants. Although previously announced results showed the trial did not reach statistical significance on the primary or secondary endpoints, pre-specified and post hoc analyses show a NurOwn-induced treatment effect across both primary and secondary efficacy outcomes in those with less advanced disease.
See -
Muscle & Nerve- "A Randomized Placebo-Controlled Phase III Study of Mesenchymal stem cells induced to secrete high levels of neurotrophic factors in Amyotrophic Lateral Sclerosis."- Merit E. Cudkowicz MD, Stacy R. Lindborg PhD, Namita A. Goyal MD, Robert G. Miller MD, Matthew J. Burford MD, James D. Berry MD, Katharine A. Nicholson MD, Tahseen Mozaffar MD … et. al., First published: 10 December 2021 https://doi.org/10.1002/mus.27472.