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)

Teijin

Status and phase

Completed

Phase 2

Phase 1

Conditions

Acute Ischemic Stroke

Treatments

Biological: JTR-161

Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04608838

JTR-161-201

Details and patient eligibility

About

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

Enrollment

79 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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
1. Severe liver dysfunction
2. Severe kidney dysfunction
3. Severe heart failure
4. 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.)