Data from the initial patients in BrainStorm Cell Therapeutics’ ALS (Lou Gehrig’s Disease) phase I/II human clinical trial treated with its NurOwn technology showed it did not present any significant side effects and the NurOwn treatment has so far proven to be safe, according to BrainStorm.
In addition, even though it is a safety trial, the early clinical follow up of patients treated with the stem cells show indications of beneficial clinical effects, such as an improvement in breathing and swallowing ability as well as in muscular power, according to Professor Dimitrios Karussis, who is leading the clinical trial at Hadassah Medical Center in Israel.
After reviewing the safety data from the first four patients, the Hadassah Medical Center ethical committee granted approval for the trial to advance to transplanting the next patients.
The ALS phase I/II human clinical trial is being performed at Hadassah Medical Center in Israel in collaboration with BrainStorm and is utilizing BrainStorm’s NurOwn technology for growing and modifying autologous adult human stem cells to treat ALS (amyotrophic lateral sclerosis). The initial phase of the study is designed to establish the safety of NurOwn and will later be expanded to assess efficacy.