Statement on Expanded Access/Compassionate Use
We are currently 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 dedicating all our resources to moving forward with the clinical development program for NurOwn® and initiating the 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.
The personalized medicine nature of NurOwn® stem cell therapy adds to the complexity for its provision it under an expanded access/compassionate use program. The product is manufactured using a process that involves taking a sample of bone marrow from a patient and then sending the bone marrow to a manufacturing facility where Mesenchymal Stem Cells are isolated and grown under carefully managed conditions.
On July 17, 2017, together with the Northeast Amyotrophic Lateral Sclerosis Consortium (NEALS), we conducted an educational webinar to update the ALS community on NurOwn® Clinical Development Program. The Webinar can be accessed below:
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.
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