Japanese OMI Treatment With Kit-positive Cells for Enhanced Regeneration

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Heart Failure, Old Myocardial Infarction

Intervention / Treatment
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* Biological: Stem cells administered to participants


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac stem cells, c-kit