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)

NCT04608838 | Completed Phase 1 DMC

• 1 other identifier: JTR-161-201
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke

Outcome Measures

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.

  91 days

Secondary Outcomes (11)

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

  366 days

• Percentage of patients who achieved BI ≥ 95

  366 days

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

  91 days

• Changes in EQ-5D-5L scores

  366 days

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

  91 days

Study Arms (2)

JTR-161

EXPERIMENTAL

Biological: JTR-161

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

JTR-161 BIOLOGICAL

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

JTR-161

Placebo BIOLOGICAL

Placebo will be suspended and administered in an intravenously infusion.

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teijin Pharma Limited: lead

Study Sites (1)

Nippon Medical School Hospital

Bunkyo-ku, Tokyo, 113-8602, Japan

Location

Related Publications (1)

• 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.

  PMID: 35613802 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Some care providers who involved in the preparation or administration of dosing solutions are unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: October 29, 2020
• Study Start: January 30, 2019
• Primary Completion: February 15, 2021
• Study Completion: November 24, 2021
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)