Kadimastem Receives Approval for ALS Patient Clinical Trial

Kadimastem announced it had received approval from the IRB of the Hadassah Ein Kerem Hospital for the phase 1/2a clinical trial in ALS patients using the cell therapy product developed by the company. The commencement of the clinical trial is subject to the approval of Ministry of Health's Supreme Committee for clinical trials in humans, which is expected to convene in the upcoming months.

After receiving the Ministry of Health's approval, the company intends to commence the trial in ALS patients under the Ministry's supervision. The trial will include 21 patients and will be conducted by the Department of Neurology of the Hadassah Ein-Kerem Medical Center in Ein-Kerem, a world-leading center in the field of ALS.

Kadimastem's product, AstroRx is a cell-based treatment for ALS, based on astrocytes produced from stem cells. Kadimastem's unique technology enables large-scale production of the cells according to Good Manufacturing Practices (GMP) standard. The cells will be injected into the patients' spinal fluid using a standard injection procedure, performed routinely in hospitals worldwide.

"The approval of the Hadassah Hospital IRB is a very important milestone towards the clinical trial and for the company," Yossi Ben-Yossef, the company's CEO, said. "During the trial, ALS patients will be treated for the first time using the unique cell-based product developed by the company, which is the result of years of innovative research. We believe that we can introduce a breakthrough in the field, and we are hoping to repeat the good results we have demonstrated so far in humans as well."