A clinical study to determine the safety and effectiveness of intracoronary infusion of autologous c-kit-positive cardiac stem cells in Japanese patients with ischemic cardiomyopathy. (JOKER trial)
Active, not recruiting
- Conditions
- Chronic ischemic heart failure
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
Adult with ability to provide informed consent.
Left ventricular ejection fraction less than 40%.
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 assignment
- Primary Outcome Measures
Name Time Method Frequency of adverse events 1, 3, 6, 9, 12, 15, 18, 21, 24 months after the cell infusion Frequency of adverse events (death, ventricular arrhythmia, infection, bleeding, myocardial infarction, cardiac tumor, brain stroke, peripheral embolism, etc.)
Severity of adverse events 1, 3, 6, 9, 12, 15, 18, 21, 24 months after the cell infusion Severity of adverse events (death, ventricular arrhythmia, infection, bleeding, myocardial infarction, cardiac tumor, brain stroke, peripheral embolism, etc.)
- Secondary Outcome Measures
Name Time Method