Japanese OMI Treatment With Kit-positive Cells for Enhanced Regeneration (JOKER)

Japanese OMI Treatment With Kit-positive Cells for Enhanced Regeneration Trial

The purpose of this study is to determine the safety and effectiveness of intracoronary infusion of autologous cardiac stem cells in patients with ischemic cardiomyopathy.

Study Overview

• Status: Unknown
• Conditions: Chronic Heart Failure; Old Myocardial Infarction
• Intervention / Treatment: Biological: Stem cells administered to participants

Detailed Description

This phase I trial will involve 6 patients suffering from chronic ischemic cardiomyopathy and congestive heart failure, to be compared with historical control subjects. This study will be conducted as a collaborative project between the Sakakibara Heart Institute and the CellBank of Japan. The trial is designed to assess the safety and effectiveness of autologous administration of 1,000,000 c-kit-positive cardiac stem cells (CSCs) via intracoronary route following cultivation. The preliminary eligibility criteria will utilize a left ventricular ejection fraction (LVEF) less than 40% measured by echocardiography. During the coronary artery bypass grafting (CABG) surgery, a part (less than 1 gram) of the right atrial appendage (RAA) will be harvested and frozen. When the LVEF is less than 40% after the CABG surgery, the subject will be enrolled as a candidate for the delivery of CSCs, which will be selected from the RAA tissue and cultured for a few months for expansion. The outcome will be evaluated by adverse events as well as cardiac functions.

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 183-0003
    • Sakakibara Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult with ability to provide informed consent.
• Left ventricular ejection fraction less than 40% as evidenced by echocardiogram.
• Scheduled for elective surgical revascularization within 2 months.

Exclusion Criteria:

• Positive for HBs-Ag, HCV-Ab, HIV-Ab, or tests for syphilis.
• Diabetic HbA1c greater than 8.5%.
• Pregnant women.
• Scheduled for additional interventions including ventriculoplasty.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Stem cells administered to participants	Biological: Stem cells administered to participants; Patients in this arm will receive intracoronary infusion of 1,000,000 autologous c-kit positive cardiac stem cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monitoring adverse events	Including death, ventricular arrhythmia, bleeding, myocardial infarction, cardiac tumor, brain stroke, peripheral embolism	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NYHA classification	Measurement of symptom	2 years
Serum NT-proBNP	Measurement of cardiac function	2 years
Electrocardiogram	Measurement of arrhythmia	2 years
Chest X-ray	Measurement of cardiac function	2 years
Cardiopulmonary exercise test	Measurement of cardiopulmonary function	2 years
Echocardiogram	Measurement of cardiac function	2 years
Magnetic resonance imaging	Measurement of cardiac function	2 years
Myocardial scintigraphy	Measurement of myocardial viability	2 years

Collaborators and Investigators

• Sponsor: Sakakibara Heart Institute
• Collaborators: CellBank of Japan

Publications and helpful links

General Publications

• Chugh AR, Beache GM, Loughran JH, Mewton N, Elmore JB, Kajstura J, Pappas P, Tatooles A, Stoddard MF, Lima JA, Slaughter MS, Anversa P, Bolli R. Administration of cardiac stem cells in patients with ischemic cardiomyopathy: the SCIPIO trial: surgical aspects and interim analysis of myocardial function and viability by magnetic resonance. Circulation. 2012 Sep 11;126(11 Suppl 1):S54-64. doi: 10.1161/CIRCULATIONAHA.112.092627.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: c-kit; cardiac stem cells
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: PB3170012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No