Title
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)
An Exploratory, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety and Efficacy of JTR-161 in Patients With Acute Ischemic Stroke
Phase
Phase 1/Phase 2Lead Sponsor
Teijin Pharma LimitedStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Acute Ischemic StrokeIntervention/Treatment
JTR-161 ...Study Participants
79The 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
JTR-161 (1 or 3 × 10^8 cells/subject) will be suspended and administered in an intravenously infusion.
Placebo will be suspended and administered in an intravenously infusion.
Inclusion Criteria: Patients who have ischemic strokes in the anterior circulation Patients whose mRS is 0 or 1 prior to the onset of ischemic stroke Patients whose NIHSS score of ≥5 to ≤20 at screening Patients who can be administered dosing solutions within 48 h of stroke onset Exclusion Criteria: Patients who have new ischemic lesion in the cerebellum or brainstem Patients whose consciousness level drops severely Patients whose infarct area is widespread Patients who have a clinically significant hemorrhagic transformation Patients who had seizures after onset of ischemic stroke Patients who have medical history of a neurological event such as stroke or clinically significant head trauma within 180 days prior to giving informed consent Patients who have poor blood pressure control Patients who have poor glycaemic control Patients who have one of the following complications Severe liver dysfunction Severe kidney dysfunction Severe heart failure Severe pulmonary dysfunction Patients who have severe infections Patients who have any neurological disorder affecting informed consent or study assessments Patients who have the malignant tumor, or medical history of malignant tumor within 2 years prior to the onset of ischemic stroke Patients who have a contraindication for MRI Patients who have thrombocytopenia Patients who have medical history of allergy to products derived from human tissues, bovine or porcine Patients who have medical history of allergy to streptomycin Patients who have undergone splenectomy in the past Patients who have a possibility of transient ischemic attack Patients who are scheduled to undergo revascularization (carotid endarterectomy, stent placement etc.)
