Cell therapy for CNS diseases

Abstract

We conducted both a clinical trial (Phase III confirmatory trial) of intravenous infusion of autologous mesenchymal stem cells for cerebral infarction patients, and a clinical trial (Phase II) using the same stem cells for spinal cord injury patients. The objectives of these studies were to examine the feasibility, safety, and efficacy of cell therapy using auto serum‒expanded autologous mesenchymal stem cells derived from bone marrow in patients. Inclusion criteria for the stroke study were: 1)cerebral infarction onset within 40 days, 2) supra‒ tentorial cerebral infarction (NINDS-III 1990) diagnosed by MRI (or CT), MRA (3D‒CTA or DSA), ECG, chest X‒ray etc., 3)classified under grade 4 or 5 on mRS (modified Rankin scale), 4) age between 20 to 80, and 5)written informed consent from the subjects and legal representative is provided. Inclusion criteria for the spinal cord injury trial were: 1) spinal cord injury onset within 14 days, 2) cervical spinal cord injury diagnosed by MRI (or CT), etc., 3) classified grade A, B, C on the ASIA scale, 4age between 20 to 70, and 5)written informed consent from the subjects and legal representative is provided.