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Research on advanced intervention using novel bone marrOW stem cell (RAINBOW) : a study protocol for a phase I, open-label, uncontrolled, dose-response trial of autologous bone marrow stromal cell transplantation in patients with acute ischemic stroke

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Title: Research on advanced intervention using novel bone marrOW stem cell (RAINBOW) : a study protocol for a phase I, open-label, uncontrolled, dose-response trial of autologous bone marrow stromal cell transplantation in patients with acute ischemic stroke
Authors: Shichinohe, Hideo Browse this author →KAKEN DB
Kawabori, Masahito Browse this author →KAKEN DB
Iijima, Hiroaki Browse this author
Teramoto, Tuyoshi Browse this author
Abumiya, Takeo Browse this author →KAKEN DB
Nakayama, Naoki Browse this author →KAKEN DB
Kazumata, Ken Browse this author
Terasaka, Shunsuke Browse this author →KAKEN DB
Arato, Teruyo Browse this author
Houkin, Kiyohiro Browse this author →KAKEN DB
Keywords: Acute ischemic stroke
Bone marrow stromal cells
Cell therapy
Regenerative medicine
Intraparenchymal injection
Platelet lysate
Bio-imaging
Issue Date: 8-Sep-2017
Publisher: BioMed Central
Journal Title: BMC neurology
Volume: 17
Start Page: 179
Publisher DOI: 10.1186/s12883-017-0955-6
Abstract: 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, 18F-fuorodeoxyglucose positron emission tomography, and 123I-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. Trial registration: The trial was registered at The University Hospital Medical Information Network on February 22, 2017 (UNIN ID: UMIN000026130). The findings of this trial will be disseminated to patients and through peer-reviewed publications and international presentations.
Rights: http://creativecommons.org/licenses/by/4.0/
Type: article
URI: http://hdl.handle.net/2115/67548
Appears in Collections:北海道大学病院 (Hokkaido University Hospital) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 七戸 秀夫

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