Date: 2015-02-03
Type of information: DSMB assessment
phase: 2
Announcement: DSMB assessment
Company: BrainStorm Cell Therapeutics (USA - Israel)
Product: NurOwn™
Action
mechanism: stem cell therapy. NurOwn™ cells are autologous bone marrow-derived mesenchymal stromal cells. These mesenchymal stem cells (MSCs) have been induced, under BrainStorm’s proprietary methods, to secrete a variety of neurotrophic factors. This novel cell-therapeutic approach is expected to effectively deliver Neurotrophic factors, which are potent survival factors for neurons, directly to the site of damage.
Disease: amyotrophic lateral sclerosis (ALS)
Therapeutic area: Neurodegenerative diseases - Rare diseases
Country: USA
Trial
details: This multi-center, randomized, double blind, placebo controlled study evaluates the safety and efficacy of autologous transplantation of Neurotrophic factors-secreting Mesenchymal Stromal Cells (MSC-NTF, NurOwn™) in patients with ALS.(NCT02017912).
Latest
news: * On February 3, 2015, BrainStorm Cell Therapeutics, a developer of adult stem cell technologies for neurodegenerative diseases, announced that the Data and Safety Monitoring Board (DSMB) met to conduct its first safety review of the randomized, double-blind, placebo-controlled phase 2 clinical trial of NurOwn™ in amyotrophic lateral sclerosis (ALS) that BrainStorm is conducting at three academic medical centers in the U.S. The DSMB recommended that the study continue as planned. The DSMB reviewed safety data collected through a cutoff date in January 2015, and did not find any lab abnormalities, adverse events or significant protocol deviations that would be cause for concern.
