Date: May 17, 2011
Summary;
BrainStorm Inc., a leading developer of adult stem cell technologies and therapeutics, and Hadasit, the technology transfer company of the Hadassah Medical Organization, announced today that Israel's Ministry of Health (MOH) has approved the Phase I/II clinical trial of NurOwn™, BrainStorm’s autologous stem cell therapy for people with amyotrophic lateral sclerosis (often referred to as ALS or Lou Gehrig's Disease). BrainStorm is the first company to receive approval from the MOH for a differentiated stem cell-based therapy.
About the Trial
The Phase I/II clinical trial will be conducted by a joint team headed by the principal investigator Prof. Dimitrios Karussis, M.D., Ph.D., Director of the Center for Multiple Sclerosis in the Department of Neurology at the Hadassah Medical Center in Jerusalem, and a scientific team from BrainStorm headed by Prof. Eldad Melamed. The initial phase of the study is designed to establish the safety of NurOwn™ and will later be expanded to assess efficacy.
Patients will be transplanted with stem cells derived from their own bone marrow and treated with Brainstorm's NurOwn™ stem cell technology. The trial will include a total of 24 patients, twelve in an advanced stage of the disease and twelve in an early stage. The patients will be examined at regular intervals and followed for six months post transplantation. Additional information regarding the Phase I/II clinical trial is provided by the Hadassah Medical Center at ClinicalTrials.gov.
Reuters published a news story about the trial today. The lead follows below:
May 17, 2011 8:00am EDT
BrainStorm Cell Therapeutics Inc.received approval from Israel's Health Ministry for a clinical trial of its adult stem cell therapy for people with amyotrophic lateral sclerosis (ALS). ...BrainStorm expects to begin treating patients in the coming weeks and will work with Jerusalem's Hadassah Medical Center.
