Hybrid biotherapy involving autologous human cardiac stem cell transplantation combined with the controlled release of bFGF using a gelatin hydrogel sheet to treat severe refractory heart failure with chronic ischemic cardiomyopathy

Phase 1

• Conditions: severe refractory heart failure with chronic ischemic cardiomyopathy

• Registration Number: JPRN-UMIN000002518
• Lead Sponsor: Kyoto Prefectural University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-01
• Study Completion: 2012-10-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

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 *1an indication for LV aneurysmectomy; patients with over 2 segments of dyskinesis area *2contra-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 *3The screening of gelatin allergy is necessary for all patients by gelatin patch test and gelatin-IgE

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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