BrainStorm Cell Therapeutics is a clinical-stage company that is developing adult stem cell technologies for neurodegenerative diseases, with a focus on ALS. The company controls exclusive worldwide rights to develop and commercialize the NurOwn technology through a licensing agreement that it signed with Ramot, the technology transfer arm of Tel Aviv University in Israel.
NurOwn®
BrainStorm Cell Therapeutics’ NurOwn technology is a novel adult stem cell therapy that utilizes autologous (“self-derived”) bone marrow cells to address neurodegenerative diseases. The company uses a proprietary process to engineer a patient’s cells outside the body to produce and secrete factors that support neuronal survival.
Amyotrophic lateral sclerosis (ALS), also known as motor neurone disease (MND) or Lou Gehrig’s disease, is a condition in which neurons controlling voluntary muscles cease to function, creating muscle weakness, muscle wasting and spasms, as well as difficulty with bodily functions, including speaking, eating, and breathing.
If BrainStorm Cell Therapeutics achieves successful endpoints in its Phase 3 trial, NurOwn could become the first cell therapy for the treatment of ALS, making it a revolutionary new approach to a devastating disease.
To date, NurOwn has been used within approximately 75 ALS patients in clinical trials underway in the U.S. and Israel.
Cell Manipulation Core Facility (CMCF) at Dana Farber
According to Dana Farber, the Cell Manipulation Core Facility (CMCF) at the Dana-Farber Cancer Institute (DFCI) was created to be a “manufacturing facility for production of safe and effective novel cellular component therapies, that meet regulatory guidelines for clinical use and enable cellular therapies to be translated from the bench to bedside.”
Benefits to Brainstorm Cell Therapeutics of partnering with a cell therapy manufacturing partner include scalability, access to technical expertise without overhead costs, and additional manufacturing space, among other benefits.
On January 3, 2018, BrainStorm Cell Therapeutics also received Good Manufacturing Practice (GMP) approval from the Israel Ministry of Health (MoH) for its Israeli contract manufacturing facility. According to Brainstorm, “This approval paves the way for the company’s application to the Israel MoH for the treatment of ALS patients in Israel for a fee, under the newly introduced Hospital Exemption regulation. ”
To learn more about cell therapy manufacturing partners, view the “Global Database of Cell and Gene Therapy CMOs / CDMOs.”
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