A glimmer of hope for ALS sufferers and their families as BrainStorm Cell Therapeutics announces positive interim results in its Phase I clinical trial to test the safety and efficacy of its adult stem cell treatment of the lethal disease.
The Israeli company — an innovative developer of adult stem cell technologies and Central Nervous System therapeutics — reported indications that the treatment improved the condition of the first six patients enrolled in the study.
“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,” said Prof. Dimitrios Karussis, who is leading the clinical trial at Hadassah Medical Center. “This may represent the biggest hope in this field of degenerative diseases, like ALS.”
BrainStorm’s innovative technology grows and modifies adult stem cells to treat ALS (amyotrophic lateral sclerosis) and other degenerative diseases.
“We take bone marrow from ALS patients and grow it in sterile conditions at Hadassah. In one month, a few cells grow to 100 million cells,” BrainStorm’s acting CEO Adrian Harel told ISRAEL21c in an earlier interview. “Our ‘trick’ is causing the cells to differentiate so that they secrete proteins that are important for communication between muscles and nerves. Scientists think that in ALS there is a discontinuation of communication between muscle and nerve.”
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.
“We are happy to report that the first patients treated with our NurOwn technology did not present any significant side effects. This supports and strengthens our belief and trust in our technology. Based on the interim safety report, the hospital ethical and safety committee granted the company approval to proceed with treating the next patients. We are pleased with the progress we are making and look forward to continuing to demonstrate the safety of NurOwn in the future,” said Chaim Lebovits, BrainStorm’s President.
The ALS Phase I/II human clinical trial is being performed at Hadassah Medical Center in Israel in collaboration with BrainStorm and is utilizing the company’s NurOwn technology for growing and modifying autologous adult human stem cells to treat ALS, which is also known as Lou Gehrig’s Disease.
The company warned of over-optimism, citing the need for further studies and more data to really assess whether BrainStorm’s treatment is a breakthrough in stem cell treatments. But BrainStorm’s scientists did acknowledge these results offer “hope that doesn’t exist right now.”