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Trial record 1 of 1 for:    NCT04608838
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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) (J-REPAIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04608838
Recruitment Status : Completed
First Posted : October 29, 2020
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Teijin Pharma Limited

Study Description
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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


Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Biological: JTR-161 Biological: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Some care providers who involved in the preparation or administration of dosing solutions are unblinded.
Primary Purpose: Treatment
Official Title: An Exploratory, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety and Efficacy of JTR-161 in Patients With Acute Ischemic Stroke
Actual Study Start Date : January 30, 2019
Actual Primary Completion Date : February 15, 2021
Actual Study Completion Date : November 24, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
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Arm Intervention/treatment
Experimental: JTR-161 Biological: JTR-161
JTR-161 (1 or 3 × 10^8 cells/subject) will be suspended and administered in an intravenously infusion.
Placebo Comparator: Placebo Biological: Placebo
Placebo will be suspended and administered in an intravenously infusion.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04608838


Locations
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Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan, 113-8602
Sponsors and Collaborators
Teijin Pharma Limited
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Teijin Pharma Limited
ClinicalTrials.gov Identifier: NCT04608838    
Other Study ID Numbers: JTR-161-201
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Teijin Pharma Limited:
Acute Ischemic Stroke
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis