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

Sakakibara Heart Institute

Status and phase

Unknown

Phase 1

Conditions

Chronic Heart Failure

Old Myocardial Infarction

Treatments

Biological: Stem cells administered to participants

Study type

Interventional

Funder types

Other

Identifiers

NCT03351400

PB3170012

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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