Expanded Access/Right to Try Act

Expanded Access/Compassionate Use  Policy

BrainStorm Cell Therapeutics Inc., is not offering compassionate use or expanded access to NurOwn®.  BrainStorm understands the serious unmet medical need and the urgency of people living with ALS.  We are moving forward with the clinical development program for NurOwn® and are conducting a phase 3 clinical trial that we hope will prove NurOwn® to be safe and effective for treating ALS. We believe completing the necessary clinical trial and obtaining the data needed for review and approval by the by regulatory agencies including the U.S. Food and Drug Administration (FDA) is the most expedient way to make NurOwn® available to the greatest number of patients.

 

Right to Try Policy

BrainStorm Cell Therapeutics Inc., will not make NurOwn® available under the Right to Try Pathway, at this time. Brainstorm has carefully evaluated the ethical, legal and practical aspects of the newly enacted RTT legislation in detail, and has received detailed feedback from patients, clinicians, regulatory and legal experts. We established an ethical and practical framework with four key elements that must be satisfied to be able to provide NurOwn® to ALS patients under the RTT pathway. The four elements are: providing the investigational therapy to a limited number of patients at clinical trial-experienced sites to ensure the necessary expertise and systems of care are in place to safely and effectively deliver the therapy; ensuring that patients are thoroughly educated about the benefits and risks of the investigational therapy; limiting the inclusion to patients who do not meet the phase 3 clinical trial inclusion criteria to ensure that the RTT pathway does not adversely impact the clinical trial; and lastly, finding alternative funding solutions for patients who are unable to afford the high cost of regenerative medicine cell therapies. We found practical solutions for all except the funding issue; therefore, we are unable to provide access to NurOwn® under the RTT pathway until all elements are fully satisfied.

 

Hospital Exemption Program Update- Israel

We continue to explore options and advocate to support the hospital exemption program in Israel for a limited number of patients.  Outside of Israel, we are engaged in regulatory level and health authority discussions. Please fill out this Form and we will provide updates on our progress as they become available.

If you have additional questions, feel free to reach out to us via our Contact page.

If you would like to receive our Company update e-mail alerts Sign up here.