Requests that the FDA Invite the drug sponsor, Brainstorm Cell Therapeutics, to re-file its Biologics License Application (BLA) for debamestrocel (aka NurOwn), a first-in-class, autologous, mesenchymal stem cell therapy enhanced with neurotrophic factors. Approve debamestrocel for ALS, with a Phase 4 study mandating participation in a biorepository with a natural history and exposome database. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2025-P-2109

Requests that the FDA Invite the drug sponsor, Brainstorm Cell Therapeutics, to re-file its Biologics License Application (BLA) for debamestrocel (aka NurOwn), a first-in-class, autologous, mesenchymal stem cell therapy enhanced with neurotrophic factors. Approve debamestrocel for ALS, with a Phase 4 study mandating participation in a biorepository with a natural history and exposome database.

Documents

Comments

Description

Open

Key Dates

Comment Period OpensJul 3, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Interim Response to Nicholas Warack, et al.	Dec 11, 2025	--

Comment Statistics

Total Comments

Keywords

CBER

Citizen Petition

Requests that the FDA: 1. Invite the drug

sponsor, Brainstorm Cell Therapeutics, to

re-file its Biologics License Application (BLA)

for debamestrocel (aka NurOwn), a first-in-class

autologous, mesenchymal stem cell therapy

enhanced with neurotrophic factors. 2. Approve

Data from Regulations.gov