Chronic Heart Failure, Old Myocardial Infarction
Conditions
Keywords
cardiac stem cells, c-kit
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.
Interventions
BIOLOGICALStem cells administered to participants
Patients in this arm will receive intracoronary infusion of 1,000,000 autologous c-kit positive cardiac stem cells.
Sponsors
CellBank of Japan
Sakakibara Heart Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monitoring adverse events | 2 years | Including death, ventricular arrhythmia, bleeding, myocardial infarction, cardiac tumor, brain stroke, peripheral embolism |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum NT-proBNP | 2 years | Measurement of cardiac function |
| Electrocardiogram | 2 years | Measurement of arrhythmia |
| Chest X-ray | 2 years | Measurement of cardiac function |
| NYHA classification | 2 years | Measurement of symptom |
| Echocardiogram | 2 years | Measurement of cardiac function |
| Magnetic resonance imaging | 2 years | Measurement of cardiac function |
| Myocardial scintigraphy | 2 years | Measurement of myocardial viability |
| Cardiopulmonary exercise test | 2 years | Measurement of cardiopulmonary function |
Countries
Japan
Outcome results
None listed