BrainStorm Cell Therapeutics (BCLI), 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 second group of patients in its ongoing phase IIa ALS clinical trial at the Hadassah Medical Centre in Jerusalem, Israel.
The treatment was well tolerated and no serious adverse events were observed. 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 to evaluate the safety, tolerability and preliminary efficacy of NurOwn.
“This second group of patients received 50 per cent more NurOwn cells than the first group in this trial,” explained Professor Karussis. “Given the fact that they were treated both IM and IT, they received significantly more cells than in the previous phase I study completed in our clinic,” 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.