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BrainStorm Cell Therapeutics Aligns with FDA on Phase 3b NurOwn Clinical Trial CMC Aspects

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BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, has reached an important milestone by aligning with the U.S. Food and Drug Administration (FDA) on the Chemistry, Manufacturing, and Controls (CMC) aspects of its Phase 3b clinical trial for NurOwn®, an investigational therapy for amyotrophic lateral sclerosis (ALS).

This alignment was achieved during a Type C meeting, building on the positive momentum from April 2024, when the FDA granted BrainStorm a Special Protocol Assessment (SPA) agreement. The SPA agreement provided clarity on the trial design and endpoints, significantly de-risking the regulatory aspects of the program.

Chaim Lebovits, President & CEO of BrainStorm, emphasized the importance of the meeting, stating, “This in-person Type C meeting with the FDA was an important step as we finalize preparations for our pivotal Phase 3b trial of NurOwn. We are very pleased with the outcome and are now aligned with the FDA on resolving all previously outstanding CMC questions.”

BrainStorm Cell Therapeutics is at the forefront of developing autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The company’s NurOwn® technology platform, used to produce autologous MSC-NTF cells, has received Orphan Drug designation from both the FDA and the European Medicines Agency (EMA) for ALS treatment.

BrainStorm has already completed a Phase 3 trial in ALS and a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS), both supported by significant grants.

This alignment with the FDA marks a critical advancement for BrainStorm, as it continues to work closely with the FDA to address the unmet needs of ALS patients and aims for the ultimate goal of achieving approval for NurOwn.

By achieving this milestone, BrainStorm Cell Therapeutics is well-positioned to advance its mission of developing effective treatments for neurodegenerative diseases, providing hope to patients and their families.

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