A Randomized Placebo-controlled Multicenter Trial to Evaluate the Efficacy and Safety of JTR-161, Allogeneic Human Dental Pulp Stem Cell, in Patients With Acute Ischemic stRoke (J-REPAIR)
Summary
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
Timeline
- Start
- 2019-01-30
- Primary completion
- 2021-02-15
- Completion
- 2021-11-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JTR-161 | Cell therapy | 1e+08 cells | Intravenous |
| Subject | JTR-161 | Cell therapy | 3e+08 cells | Intravenous |