Expanded access and compassionate use
BrainStorm is committed to people living with ALS and their families.
Policy
Expanded access
Our policy
BrainStorm does not offer expanded access, also known as compassionate use, and is not accepting expanded access requests. The only route to the investigational therapy is enrollment in the Phase 3b clinical trial.
We acknowledge that some people living with ALS may be unable to participate in a clinical trial, and their physicians might seek investigational treatments through Expanded Access, also known as Compassionate Use.
However, due to the personalized nature of this autologous cellular therapy and the need to complete the Phase 3b trial, access to the investigational therapy is limited to enrollment in that clinical trial. Our commitment to initiating and completing the Phase 3b trial is focused on securing approval, which will ensure the potential therapy becomes available if successful.
This policy is published under section 561A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-0).
Questions from physicians
A treating physician with a question may write to our medical team at info@brainstorm-cell.com, with "Expanded access inquiry" in the subject line, or by mail to the address in the footer of this site. Please do not send patient-identifying medical records through this website or by unencrypted email.
We aim to acknowledge receipt within ten business days. An acknowledgment confirms the message reached the right team; it is not a decision, and it does not change the policy above.
Our clinical trials
Our clinical trials page sets out which studies have run and what taking part involves. Completed studies and their registry records are published on ClinicalTrials.gov, and the record for the Phase 3b trial will be linked here once that study is registered.
BrainStorm studies on ClinicalTrials.gov (opens in a new tab)
Limitations of this policy
Publishing this policy does not guarantee access to any investigational drug and does not oblige us to provide one. This policy may be revised at any time, and any revision applies from the date it is published here.
BrainStorm's autologous MSC-NTF cell therapy (NurOwn®, debamestrocel) is investigational and has not been approved by the FDA or any other regulatory authority.