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)
- Conditions
- Acute Ischemic Stroke
- Interventions
- Biological: JTR-161Biological: Placebo
- Registration Number
- NCT04608838
- Lead Sponsor
- Teijin Pharma Limited
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
- 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
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Patients who have new ischemic lesion in the cerebellum or brainstem
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Patients whose consciousness level drops severely
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Patients whose infarct area is widespread
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Patients who have a clinically significant hemorrhagic transformation
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Patients who had seizures after onset of ischemic stroke
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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
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Patients who have poor blood pressure control
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Patients who have poor glycaemic control
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Patients who have one of the following complications
- Severe liver dysfunction
- Severe kidney dysfunction
- Severe heart failure
- Severe pulmonary dysfunction
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Patients who have severe infections
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Patients who have any neurological disorder affecting informed consent or study assessments
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Patients who have the malignant tumor, or medical history of malignant tumor within 2 years prior to the onset of ischemic stroke
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Patients who have a contraindication for MRI
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Patients who have thrombocytopenia
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Patients who have medical history of allergy to products derived from human tissues, bovine or porcine
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Patients who have medical history of allergy to streptomycin
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Patients who have undergone splenectomy in the past
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Patients who have a possibility of transient ischemic attack
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Patients who are scheduled to undergo revascularization (carotid endarterectomy, stent placement etc.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description JTR-161 JTR-161 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method The percentage of patients who achieved Excellent outcome (modified Rankin Scale [mRS] ≤1 and National Institutes of Health Stroke Scale [NIHSS] ≤1 and Barthel Index [BI] ≥95) on Day 91 in Cohort 3. 91 days
- Secondary Outcome Measures
Name Time Method Percentage of patients who achieved BI ≥ 95 366 days Percentage of patients who achieved excellent outcome (mRS ≤ 1, NIHSS ≤ 1, and BI ≥ 95) 91 days Percentage of patients who achieved mRS ≤ 1 or mRS ≤ 2 366 days Percentage of patients who achieved NIHSS ≤ 1, who achieved improvement of ≥ 75%, and who achieved improvement of ≥ 10 points 91 days Incidence of Adverse events (signs and symptoms) 366 days Percentage of patients who showed overall improvement (mRS ≤ 2, NIHSS improvement of ≥ 75%, and BI ≥ 95) 91 days Changes in Laboratory tests (hematology, blood chemistry, blood coagulation test, urinalysis) 366 days Number of participants with clinical laboratory abnormalities for each parameter
* hematology Red blood cell count, Hemoglobin, Hematocrit, Platelet count, Leukocyte count, Leukocyte formula (neutrophils, lymphocytes, monocytes, eosinophils, basophils)
* blood chemistry Total protein, Albumin, Total bilirubin, Aspartate aminotransferase , Alanine aminotransferase, Alkaline phosphatase , Lactate dehydrogenase , γ-Glutamyltransferase, Blood urea nitrogen , Creatinine, Uric acid, Sodium, Potassium, Calcium, Chloride, Creatine kinase , C-reactive protein
* blood coagulation Prothrombin time (International normalized ratio) , Activated partial thromboplastin time
* urinalysis Urine Protein, Urine GlucoseChanges in findings of imaging examination by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT). 31 days Changes in Vital signs (blood pressure [systolic/diastolic], pulse rate, body temperature) 366 days Number of participants of the vital signs abnormalities for each parameter: blood pressure (mmHg), pulse rate (bpm) and body temperature (℃).
Changes in EQ-5D-5L scores 366 days The EuroQOL 5 dimension 5-level (EQ-5D-5L) consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1="no problems", 2="slight problems", 3="moderate problems", 4="severe problems" and 5="extreme problems".
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.Changes in Oxygen saturation (SpO2) 366 days
Trial Locations
- Locations (1)
Nippon Medical School Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan