01 March 2019 | News
The objective of the trial is to evaluate the safety and efficacy of AstroRx® in patients
Israeli biotechnology company Kadimastem has announced the completion of cell transplantation (AstroRx®) in 5 patients who were enrolled in Cohort A for its clinical trial in ALS.
In preparation for this stage of the clinical trial the company has recently hired a production manager with many years of experience in the field of clinical production. The company has also upgraded the production system, increased its QA and production teams, and invested considerable resources in improving the production process.
The phase I/IIa clinical trial is being conducted by the Department of Neurology of the Hadassah Ein-Kerem Medical Center, and it is expected to include a total of 21 patients. The objective of the trial is to evaluate the safety and efficacy of AstroRx® in patients. Results for Cohort A of the trial are expected within around half a year. The company is prepared for the next cohort of patients and is expecting to receive MOH approval by April 2019.
AstroRx® contains functional healthy c derived from human embryonic stem cells that aim to protect ALS-diseased motor neurons through several mechanisms. The company's technology enables the injection of AstroRx® cells into the patient's spinal fluid with the goal of supporting the malfunctioning cells in the brain and spinal cord, slowing the progression of the disease and improving the patient's quality of life and life expectancy.