BrainStorm Cell Therapeutics announced that the data from the initial patients in its ALS phase I/II human clinical trial treated with the NurOwn technology did not present any significant side effects and that this treatment has so far proven to be safe in the first four ALS patients.
Dimitrios Karussis, who is leading the clinical trial at Hadassah Medical Center, Israel, stated: “There have been no significant side effects in the initial patients we have treated with BrainStorm’s NurOwn technology. In addition, even though we are conducting a safety trial, the early clinical follow up of the patients treated with the stem cells shows indications of beneficial clinical effects, such as an improvement in breathing and swallowing ability as well as in muscular power. I am very excited about the safety results, as well as these indications of efficacy, we are seeing. This may represent the biggest hope in this field of degenerative diseases, like amyotrophic lateral sclerosis (ALS).”
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 utilising BrainStorm’s NurOwn technology for growing and modifying autologous adult human stem cells to treat ALS, often referred to as Lou Gehrig’s disease. The initial phase of the study is designed to establish the safety of NurOwn and will later be expanded to assess efficacy.
BrainStorm’s core technology, NurOwn, is based on the scientific achievements of Eldad Melamed, former head of Neurology, Rabin Medical Center, and Tel-Aviv University, and a member of the Scientific Committee of the Michael J Fox Foundation for Parkinson’s Research, and Daniel Offen, head of the Neuroscience Laboratory, Felsenstein Medical Research Center (FMRC) at the Tel-Aviv University.
The NurOwn technology processes autologous adult human mesenchymal stem cells that are present in bone marrow and are capable of self-renewal as well as differentiation into many other cell types. Adult human bone marrow cells are induced to differentiate into astrocyte-like cells capable of releasing neurotrophic factors, including glial-derived neurotrophic factor (GDNF) by means of a specific differentiation-inducing culture medium. The ability to induce differentiation into astrocyte-like cells along with intramuscular or intrathecal (or other) delivery makes NurOwn technology highly attractive for treating ALS and Parkinson’s disease as well as multiple sclerosis and spinal cord injury.