BrainStorm submits positive phase IIa ALS trial interim safety report to IRB
BrainStorm Cell Therapeutics, a leading developer of adult stem cell technologies for neurodegenerative diseases, has submitted a favourable safety report to the hospital Helsinki Committee (IRB) for the first group of patients in its ongoing phase IIa ALS clinical trial at the Hadassah Medical Centre in Jerusalem, Israel. The company will release the preliminary efficacy data at the conclusion of the trial.
In this phase IIa dose-escalating trial, currently underway at Hadassah under the direction of principal investigator Professor Dimitrios Karussis, 12 ALS patients are receiving combined intramuscular (IM) and intrathecal (IT) administration of NurOwn cells, in three cohorts, with increasing doses. The study participants will be monitored for six months following transplantation.
“In the previous phase I study recently completed at our clinic, the trial participants received NurOwn cells via a single route of administration only,” explained Professor Karussis. “In this study, the patients are receiving treatment both IM and IT, so even the patients in the low dose group received many more cells than in the previous study,” he added.
BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases.