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# FDA, BrainStorm Cell Agree on Potential NurOwn Pathway
- URL: https://www.fdaweb.com/fda-brainstorm-cell-agree-on-potential-nurown-pathway/
- Published: 2020-02-11T12:00:00.000Z
- Updated: 2026-09-14T16:02:34.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, #legacy-id-D5146056

Senior CBER officials and executives from BrainStorm Cell Therapeutics have agreed on a potential regulatory pathway for the company’s NurOwn (autologous MSC-NTF cells) to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease). The company [says](https://finance.yahoo.com/news/brainstorm-cell-therapeutics-fda-agree-110010642.html?ref=fdaweb.com) that repeated intrathecal administration of NurOwn is currently being evaluated in a fully enrolled Phase 3 trial in ALS.

During the meeting, BrainStorm says, FDA confirmed that the Phase 3 ALS trial is collecting relevant data critical to the assessment of NurOwn efficacy. The agency officials said they would look at the “totality of the evidence” in the expected Phase 3 clinical trial data.

BrainStorm says NurOwn is a “promising investigational 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 elect a desired biological effect and ultimately slow or stabilize disease progression.”