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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)

Primary Purpose

Acute Ischemic Stroke

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

JTR-161

Placebo

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Acute Ischemic Stroke

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.)

Sites / Locations

Nippon Medical School Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

JTR-161

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Percentage of patients who achieved BI ≥ 95

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

Changes in EQ-5D-5L scores

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'.

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

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

Incidence of Adverse events (signs and symptoms)

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

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

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

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

Changes in Oxygen saturation (SpO2)

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

Full Information

NCT ID

NCT04608838

First Posted

September 8, 2020

Last Updated

June 28, 2022

Sponsor

Teijin Pharma Limited

1. Study Identification

Unique Protocol Identification Number

NCT04608838

Brief 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)

Acronym

J-REPAIR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

January 30, 2019 (Actual)

Primary Completion Date

February 15, 2021 (Actual)

Study Completion Date

November 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teijin Pharma Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Some care providers who involved in the preparation or administration of dosing solutions are unblinded.

Allocation

Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

JTR-161

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

JTR-161

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Placebo will be suspended and administered in an intravenously infusion.

Primary Outcome Measure Information:

Title

Time Frame

91 days

Secondary Outcome Measure Information:

Title

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

Time Frame

366 days

Title

Percentage of patients who achieved BI ≥ 95

Time Frame

366 days

Title

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

Time Frame

91 days

Title

Changes in EQ-5D-5L scores

Description

Time Frame

366 days

Title

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

Time Frame

91 days

Title

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

Time Frame

91 days

Title

Incidence of Adverse events (signs and symptoms)

Time Frame

366 days

Title

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

Description

Time Frame

366 days

Title

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

Description

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

Time Frame

366 days

Title

Changes in Oxygen saturation (SpO2)

Time Frame

366 days

Title

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

Time Frame

31 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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 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.)

Facility Information:

Facility Name

Nippon Medical School Hospital

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8602

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35613802

Citation

Suda S, Nito C, Ihara M, Iguchi Y, Urabe T, Matsumaru Y, Sakai N, Kimura K; J- REPAIR trial group. Randomised placebo-controlled multicentre trial to evaluate the efficacy and safety of JTR-161, allogeneic human dental pulp stem cells, in patients with Acute Ischaemic stRoke (J-REPAIR). BMJ Open. 2022 May 24;12(5):e054269. doi: 10.1136/bmjopen-2021-054269.

Results Reference

derived

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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)

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