Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease (PERSEUS)
Phase 2
- Conditions
- Hypoplastic left heart syndrome Single right ventricle Single left ventricle
- Registration Number
- JPRN-UMIN000010453
- Lead Sponsor
- Okayama University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
Not provided
Exclusion Criteria
1)Cardiogenic shock 2)A patient with unstoppable extracorporeal circulation 3)A patient with lethal, uncontrollable arrhythmia 4)A patient with a complication of coronary artery disease 5)A patient with a complication of brain dysfunction due to circulatory failure 6)A patient with malignant neoplasm 7)A patient with a complication of serious neurologic disorder 8)A patient with high-grade pulmonary embolism or pulmonary hypertension 9)A patient with high-grade renal failure 10)A patient with multiple organ failure 11)Active infection (including endocarditis) 12)Sepsis 13)Active hemorrhagic disease (e. g. gastrointestinal bleeding, injury)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure is to evaluate the cardiac function improvement by echocardiography, ventriculography, and cardiac MRI, which are conducted before and 3 months after surgical treatment.
- Secondary Outcome Measures
Name Time Method The secondary outcome measure is to determine the cardiac function improvements by three different imaging modalities at 12 months after treatment. Clinical symptoms and BNP levels will be assessed at 3- and 12-months after treatment and compared with control group.