Abstract Body: Due to the lack of effective therapies, stem cell transplantation is an anticipated treatment for ischemic stroke. Recent studies have elucidated that the bone marrow mesenchymal stem cells (MSCs) have therapeutic potential against stroke. We also reported the novel clinical trials, Research on advanced intervention using novel bone marrow stem cell(RAINBOW) study in 2020. It was a phase 1, open label, uncontrolled, dose response study. We determined the safety of autologous MSC product, HUNS001, when administered to acute ischemic stroke patients.
We started the new project, RAINBOW-2a study on Oct. 30, 2024. It is a phase 2a, open-label, uncontrolled study, with the aim to determine the safety and the effectiveness of HUNS001 (RAINBOW Inc., Sapporo, Japan) when administered to patients with chronic ischemic stroke. The enrollment is 8 patients suffering from moderate to severe neurological deficits more than 6 months passed after the onset.
About 50 mL of bone marrow is extracted from the iliac bone of the patient. The MSCs are cultured with human platelet lysate (hPL) instead of fetal calf serum (FCS). HUNS001 is administered around the infarct area stereotactically. Each patient will be given a dose of 40 million cells. Neurological scoring, MRI, 18F-FDG PET, and 123I-Iomazenil SPECT are performed for 1 year after the administration.