severe refractory heart failure with chronic ischemic cardiomyopathy
Conditions
Interventions
1. Injection of autologous human cardiac stem cell. Before proceeding with the trial, the isolated and cultured cardiac stem cell will need to reach a target of 5 x 10e5 cells/kg. Once the target num
1 year after surgery
Sponsors
Kyoto Prefectural University School of Medicine
The National Cardiovascular Center Translational Research Informatics Centre, Foundation for Biomedical Research and Innovation,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: 20 to 80 years old 2) LV function: An ejection fraction (EF)>15%, and <35% 3) AHA/ACC stage: Stage D 4) NYHA: Class III or IV 5) An indication for CABG A myocardial ischemia according to major coronary artery stenosis(>75%) 6) Viability in the infarct area: as measured by cardiac delayed hyperenhancement magnetic resonance imaging (MRI) 1. Infarct area affecting>2 contiguous LV segments in a 18-segment model 2. The number of segments which transmural extent of hyperenhancment more than 51% is less than one. Ex1. infarct area with or without bypass graft Ex2. no correlation with graft number Ex3. in case of multiple myocardial infarction, an indication for larger in infarct volume 7) written informed consent
Exclusion criteria
Exclusion criteria: 1) New onset of myocardial infarction or unstable angina within 28 days prior to study entry 2) Indication for surgical ventricular reconstruction or mitral valve repair *1 3) Contraindication for endomyocardial biopsy *2 4) Evidence for malignant disease within 3 years prior to study entry 5) Chronic hemodialysis 6) Liver Cirrhosis (ICGR 15>30%) 7) Uncontrollable diabetes mellitus (HbA1c>8.0) 8) Maximum diameter of Aortic aneurysm more than 5cm(including dissecting aneurysm) 9) Cardiogenic shock 10) Active infection (including cytomegalovirus infection) 11) Drug or alcoholic dependency 12) Positive for HIV antigen 13) Active bleeding state (gastric ulcer, cerebral bleeding, etc.) 14) Gelatin allergy *3 15) Chromosomal abnormality *1 an indication for LV aneurysmectomy; patients with over 2 segments of dyskinesis area *2 contra-indication for endomyocardial biopsy 1 cardiogenic shock 2 end-stage or uncontrollable congestive heart failure without continues infusion of catecholamine 3 complete or mobitz type AV block *3 The screening of gelatin allergy is necessary for all patients by gelatin patch test and gelatin-IgE
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety 1. major adverse cardiac event (MACE) (cardiovascular death, sustained ventricular arrhythmia, re-hospitalization for heart failure, new onset of acute cardiovascular syndrome, or cardiac tamponade which needs surgical repair) 2. serious adverse events without major adverse cardiac event 3. adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy 1. New York Heart Association (NYHA) class 2. Left ventricular ejection fraction (LVEF) as assessed by the bi-planar modified Simpson method 3. regional wall motion score in infarct area by cardiac MRI 4. infarct volume evaluated by cardiac MRI with late Gd-enhancement | — |
Countries
Japan
Contacts
Public ContactHiroaki Matsubara
Kyoto Prefectural University School of Medicine The Department of Cardiovascular medicine
Outcome results
None listed