期刊
BMC NEUROLOGY
卷 17, 期 -, 页码 -出版社
BMC
DOI: 10.1186/s12883-017-0955-6
关键词
Acute ischemic stroke; Bone marrow stromal cells; Cell therapy; Regenerative medicine; Intraparenchymal injection; Platelet lysate; Bio-imaging
资金
- Initiative for Accelerating Regulatory Science in Innovative Drug, Medical Device, and Regenerative Medicine (Ministry of Health, Labour and Welfare in Japan)
- Research Project for Practical Applications of Regenerative Medicine (Japan Agency for Medical Research and Development)
Background: Stroke is a leading cause of death and disability, and despite intensive research, few treatment options exist. However, a recent breakthrough in cell therapy is expected to reverse the neurological sequelae of stroke. Although some pioneer studies on the use of cell therapy for treating stroke have been reported, certain problems remain unsolved. Recent studies have demonstrated that bone marrow stromal cells (BMSCs) have therapeutic potential against stroke. We investigated the use of autologous BMSC transplantation as a next-generation cell therapy for treating stroke. In this article, we introduce the protocol of a new clinical trial, the Research on Advanced Intervention using Novel Bone marrOW stem cell (RAINBOW). Methods/design: RAINBOW is a phase 1, open-label, uncontrolled, dose-response study, with the primary aim to determine the safety of the autologous BMSC product HUNS001-01 when administered to patients with acute ischemic stroke. Estimated enrollment is 6-10 patients suffering from moderate to severe neurological deficits. Approximately 50 mL of the bone marrow is extracted from the iliac bone of each patient 15 days or later from the onset. BMSCs are cultured with allogeneic human platelet lysate (PL) as a substitute for fetal calf serum and are labeled with superparamagnetic iron oxide for cell tracking using magnetic resonance imaging (MRI). HUNS00101 is stereotactically administered around the area of infarction in the subacute phase. Each patient will be administered a dose of 20 or 50 million cells. Neurological scoring, MRI for cell tracking, F-18-fuorodeoxyglucose positron emission tomography, and I-123-Iomazenil singlephoton emission computed tomography will be performed for 1 year after the administration. Discussion: This is a first-in-human trial for HUNS001-01 to the patients with acute ischemic stroke. We expect that intraparenchymal injection can be a more favorable method for cell delivery to the lesion and improvement of the motor function than intravenous infusion. Moreover, it is expected that the bio-imaging techniques can clarify the therapeutic mechanisms.
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