Japanese OMI Treatment With Kit-positive Cells for Enhanced Regeneration

Phase 1

• Conditions: Chronic Heart Failure; Old Myocardial Infarction
• Interventions: Biological: Stem cells administered to participants

• Registration Number: NCT03351400
• Lead Sponsor: Sakakibara Heart Institute

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-11-14
• Study Start: 2017-11-15
• Study First Submitted QC: 2017-11-17
• Study First Posted: 2017-11-22
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-18
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Stem cells administered to participants	Stem cells administered to participants

Primary Outcome Measures

Name	Time	Method
Monitoring adverse events	2 years	Including death, ventricular arrhythmia, bleeding, myocardial infarction, cardiac tumor, brain stroke, peripheral embolism

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sakakibara Heart Institute; 🇯🇵 Tokyo, Japan