Kadimastem chose to upgrade the production rooms, for the treatment of ALS patients in the Phase 1 / 2a clinical trial, and adapt them to the stringent European production standards. The production area conforms to the Grade B level GMP (Good Manufacturing Practices) standards, with the actual production being carried out in GMP Grade A level biological hoods. The upgraded rooms have successfully undergone validation and quality assurance certifications. The production process was tested and validated and was approved by the Ministry of Health, thus completing the company's preparation for the production of the AstroRx® clinical product at a very high quality standard.
The clinical trial is being conducted in the Department of Neurology of the Hadassah Ein-Kerem Medical Center, and interim results are expected within the coming year.
