This approval will bring into motion the agreement that was signed earlier this year between BrainStorm Cell Therapeutics Inc, a leading developer of adult stem cell technologies and therapeutics, and Hadassah.
The agreement that was signed with Hadassah, through its technology transfer company Hadasit Medical Research Services and Development Co. Ltd., calls for the Company’s ALS clinical trials to be performed at Hadassah utilizing Hadassah’s state-of-the-art medical facility and physicians and their experience with injecting patients with mesenchymal stem cells.
The agreement also provides the Company with the use of a dedicated laboratory and equipment. Work at the lab will be carried out by the Company's employees under the supervision of the Company’s supervisor together with Hadassah’s supervisor of good manufacturing practice standards.
The clinical trial will be conducted by Prof. Dimitrios Karussis director of the MS center at Hadassah's department of neurology, and Prof. Tamir Ben-Hur, Head of the Neurology Department. This phase of the trial will include 24 patients only and it will test the safety of the treatment. They will be recruited from a list of patients whose medical records were already initially screened. During the next year the physicians will monitor how the patients will react to the re-implantation of stem, cells that will be taken of their own pelvis. Only then they will be able to determine if the trial was successful and start planning the next phase.