BrainStorm Cell Therapeutics (NASDAQ:BCLI) is a biotechnology company developing innovative, autologous stem cell therapies for highly debilitating neurodegenerative diseases such as
- Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig’s disease and Motor Neuron Disease)
- Multiple Sclerosis
- Parkinson’s Disease
- Huntington’s Disease
Our platform technology, NurOwn®, uses proprietary culture conditions to induce mesenchymal stem cells (MSCs) to secrete high levels of neurotrophic factors (NTFs) known to promote the survival of neurons. Our research efforts have shown that these MSC-NTF cells might be an effective tool for battling neurodegenerative diseases.
- That delivery of these neurotrophic factors to injured or degenerating neurons can prolong their survival and improve their function.
- That MSCs, which possess beneficial properties including the ability to home to sites of injury and to dampen immune responses, represent the ideal biological delivery system for neurotrophic factors.
MSC-NTF cells have been shown in the laboratory and in animal models of neurodegenerative diseases to have a beneficial effect, and BrainStorm and our academic collaborators have published over 20 papers in leading scientific journals demonstrating NurOwn’s mechanism of action and efficacy. We invite you to view the Technology and Pipeline areas of our website to learn more.
NurOwn® in the Clinic
Human testing of MSC-NTF cells was initiated 2010 in ALS patients, a program that has now advanced to phase 2 clinical trials in the United States and Israel. We have completed two single-arm clinical trials at Hadassah Medical Center in Jerusalem, in which a total of 26 ALS patients received MSC-NTF cells. These studies established the safety profile of the cells and provided indications of a treatment benefit.
We recently completed a 48 patient randomized, double-blind, placebo-controlled phase 2 study of MSC-NTF cells at three prestigious academic medical centers in the United States.
NurOwn® has received Fast Track status from the US Food and Drug Administration (FDA) in ALS, and has additionally been granted Orphan Status for ALS by the FDA and the European Medicines Agency (EMA).