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Completed

NCT Number: NCT04608838

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)

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

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Nippon Medical School Hospital

Bunkyo-ku, Tokyo, 113-8602, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

JTR-161

Biological

JTR-161 (1 or 3 × 10^8 cells/subject) will be suspended and administered in an intravenously infusion.

Placebo

Biological

Placebo will be suspended and administered in an intravenously infusion.

Primary outcomes

  1. 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.

    Time frame: 91 days

Secondary outcomes

  1. Percentage of patients who achieved mRS ≤ 1 or mRS ≤ 2

    Time frame: 366 days

  2. Percentage of patients who achieved BI ≥ 95

    Time frame: 366 days

  3. Percentage of patients who achieved NIHSS ≤ 1, who achieved improvement of ≥ 75%, and who achieved improvement of ≥ 10 points

    Time frame: 91 days

  4. Changes in EQ-5D-5L scores

    Time frame: 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'.

  5. Percentage of patients who achieved excellent outcome (mRS ≤ 1, NIHSS ≤ 1, and BI ≥ 95)

    Time frame: 91 days

  6. Percentage of patients who showed overall improvement (mRS ≤ 2, NIHSS improvement of ≥ 75%, and BI ≥ 95)

    Time frame: 91 days

  7. Incidence of Adverse events (signs and symptoms)

    Time frame: 366 days

  8. Changes in Laboratory tests (hematology, blood chemistry, blood coagulation test, urinalysis)

    Time frame: 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 Glucose

  9. Changes in Vital signs (blood pressure [systolic/diastolic], pulse rate, body temperature)

    Time frame: 366 days

    Number of participants of the vital signs abnormalities for each parameter: blood pressure (mmHg), pulse rate (bpm) and body temperature (℃).

  10. Changes in Oxygen saturation (SpO2)

    Time frame: 366 days

  11. Changes in findings of imaging examination by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT).

    Time frame: 31 days

Sponsors and collaborators

Lead sponsor

Teijin Pharma Limited

Industry

Registry information

Official study title

An Exploratory, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety and Efficacy of JTR-161 in Patients With Acute Ischemic Stroke

Acronym: J-REPAIR

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2020
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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