BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapies for neurodegenerative diseases, has announced a new clinical Phase II trial for Alzheimer’s disease (AD). The company plans to conduct a 52-week, open-label and proof-of-concept trial to evaluate the safety and efficacy of NurOwn in people with prodromal to mild AD. The clinical trial will be conducted in several clinical trial sites in the Netherlands and France. 40 participants will receive three doses of NurOwn during 8 weeks. The company reported that the protocol has been submitted for EU regulatory approval.
NurOwn is a cell therapy that uses mesenchymal stem cells. These cells have the capacity to generate different cell types. BrainStorm has completed several clinical trials evaluating NurOwn and has recently fully enrolled a Phase III trial with NurOwn for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received acceptance from the US Food and Drug Administration (FDA) to initiate a Phase II open-label multicentre trial in progressive multiple sclerosis.