Autologous Cellular Therapy MSC-NTF Cells MSC-NTF Cell Production Publications Science Autologous Cellular Therapy Autologous cellular therapy has recently emerged as a credible and practical treatment option for cancer and other highly debilitating diseases. The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. The Phase 3 clinical trial's primary efficacy endpoint, a responder analysis evaluating the proportion of participants who experienced a 1.25 points per month improvement in the post-treatment Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) slope, was powered on assumed treatment response rates of 35% on NurOwn versus 15% on Placebo. 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. Secondary endpoints included the percentage of patients with disease progression halted or improved, ALSFRS-R change from baseline, combined analysis of function and survival, slow vital capacity, tracheostomy-free survival, overall survival and cerebrospinal fluid biomarker measurements. Toggle, Autologous Cellular BrainStorm is also conducting an FDA-cleared Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). Chauk. Phase 3 Detailed Description: Neurotrophic factors (NTFs) are potent survival factors for embryonic, neonatal, and adult neurons and are considered potential therapeutic candidates for ALS. "More detailed analyses will be shared at upcoming scientific conferences and in subsequent publications.  We are committed to learning as much as we can from this trial and to partner with the ALS community to progress our collective understanding of ALS, which in turn will help us to continue to bring forward new treatments for this unrelenting disease.". Those interested in listening to the conference call live via the internet may do so by visiting the "Investors & Media" page of BrainStorm's website at www.ir.brainstorm-cell.com and clicking on the conference call link. Phase 3 Clinical Trial in ALS BrainStorm has completed a randomized, double-blind, placebo-controlled phase 3 trial of autologous MSC-NTF cells following repeat administration in patients in ALS at six U.S. sites (NCT03280056). Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). We also carried out pre-specified statistical modeling designed to predict clinical response with high sensitivity and specificity based on ALS biomarkers and ALS Function and confirmed that NurOwn treatment outcomes could be predicted by baseline ALS function as well as key CSF neurodegenerative and neuroinflammatory biomarkers. In this subgroup, there were 34.6% responders who met the primary endpoint definition on NurOwn and 15.6% on Placebo (p=0.288), and the average change from baseline to week 28 in ALSFRS-R total score was -1.77 on NurOwn and -3.78 on Placebo (p=0.198), an improvement of 2.01 ALSFRS-R points favoring NurOwn. Contact the source provider Comtex at editorial@comtex.com. 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. Results from the trial showed that NurOwn® was generally well tolerated in this population of rapidly progressing ALS patients. That NurOwn® was generally well tolerated in this population of rapidly progressing ALS patients trial of autologous cells. In pre- to post- treatment slope of 1.25 or more is substantial and clinically important a developer... 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