BrainStorm Cell Therapeutics has begun training the cell manufacturing team at City of Hope’s Center for Biomedicine and Genetics to produce NurOwn adult stem cells for a Phase 3 clinical trial in patients with amyotrophic lateral sclerosis (ALS).
Los Angeles-based City of Hope will be the clinical supplier of NurOwn stem cells for all U.S. medical centers participating in the study.
NurOwn uses a patient’s own mesenchymal stem cells (MSCs), isolates them the patient’s bone marrow, and expands and induces them to differentiate into NurOwn (MSC-NTF) cells. The cells with neuro-protective properties are then transplanted back into the patient. NurOwn spurs production of growth factors that help neurons survive — a critical step in treating neurodegenerative diseases such as ALS.
BrainStorm develops and commercializes NurOwn in partnership with Ramot, the business engagement unit of Israel’s Tel Aviv University.
Following completion of a Phase 2 clinical trial that showed that NurOwn was safe and well tolerated — and able to halt or reverse ALS progression — the U.S. Food and Drug Administration (FDA) gave BrainStorm permission to start a Phase 3 trial. The randomized, double-blind, placebo-controlled multi-dose Phase 3 clinical trial will be conducted at multiple U.S. and Israeli sites, with enrollment of patients starting later this year.
The FDA has accepted some components of the Phase 3 program protocol to support a Biologic License Application for NurOwn.
“City of Hope is one of the world’s pre-eminent cell product manufacturing centers,” Chaim Lebovits, president and CEO of BrainStorm, said in a news release. “The transfer of our proprietary autologous cell production technology to City of Hope’s production team reflects the rapid progress we are making in preparing for our Phase 3 ALS clinical study and will ensure that we have adequate high-quality cell-production capacity in place when we begin the Phase 3 study. We welcome them as a clinical partner and appreciate their commitment to the success of this important clinical program.”
Added Joseph Gold, manufacturing director at the Center for Biomedicine and Genetics: “BrainStorm’s NurOwn technology represents an innovative approach to treating ALS. City of Hope is excited to play a role in treating this devastating disease.”