For people living with ALS, and those who care for them
What ALS is, which studies BrainStorm has conducted and plans to conduct, how expanded access works, and where to find support.
Current status
Special Protocol Assessment for the Phase 3b trial in ALS
BrainStorm received written agreement from the U.S. Food and Drug Administration, under a Special Protocol Assessment, on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis.
The SPA agreement validates the clinical trial protocol and statistical analysis plan, demonstrating their adequacy for addressing objectives that support a future Biologics License Application in ALS.
- Study
- ENDURANCE (BCT-006-US) · Phase 3b
- Study population
- People earlier in the course of ALS
- Entry criteria
- Symptom onset within 24 months; SVC ≥ 65% predicted
- Standard of care
- Concomitant approved treatment permitted
For patients and caregivers
- 01
About ALS
What amyotrophic lateral sclerosis is, what happens to motor neurons, and what the progressive loss of muscle action means.Read more - 02
Clinical trials
Which studies have run in ALS and progressive MS, where the Phase 3 sites were, and who the principal investigators are.Read more - 03
Expanded access
How Expanded Access, also known as Compassionate Use, is handled while the Phase 3b trial is being completed.Read more - 04
Resources
Organizations offering education and support to people diagnosed with ALS and MS, and to their families.Read more
BrainStorm's autologous MSC-NTF cell therapy (NurOwn®, debamestrocel) is investigational and has not been approved by the FDA or any other regulatory authority. This page is not medical advice - please speak with your own care team.