急性虚血性脳卒中患者における同種ヒト歯髄幹細胞JTR-161の有効性および安全性を評価するための無作為化プラセボ対照多施設共同試験（J-REPAIR）

基本情報

NCT ID

NCT04608838

ステータス

完了

試験のフェーズ

第1/第2相

試験タイプ

介入

目標被験者数

79

治験依頼者名

Teijin Pharma Limited

概要

The objective of this study is to evaluate the safety and efficacy of a single intravenous administration of JTR-161 (allogeneic stem cell product derived from the dental pulp of healthy adult humans) to patients with acute ischemic stroke. This study is comprised of 3 cohorts and conducted in the order of Cohort 1, Cohort 2 and Cohort 3. Cohort 1 Arm-1: JTR-161, 1 × 10\^8 cells/subject, 6 subjects Arm-2: Placebo, 2 subjects The Data and Safety Monitoring Board (DSMB) and the Sponsor will decide whether Cohort 2 can be initiated or not. Cohort 2 Arm-1: JTR-161, 3 × 10\^8 cells/subject, 6 subjects Arm-2: Placebo, 2 subjects DSMB and the Sponsor will decide whether Cohort 3 can be initiated or not and the dose of JTR-161 in Cohort 3. Cohort 3 Arm-1: JTR-161, 1 × 10\^8 cells/subject or 3 × 10\^8 cells/subject, 30 subjects Arm-2: Placebo, 30 subjects

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)