Status:
COMPLETED
AutoLogous Human CArdiac-Derived Stem Cell to Treat Ischemic cArdiomyopathy (ALCADIA)
Lead Sponsor:
Naofumi Takehara
Collaborating Sponsors:
National Cerebral and Cardiovascular Center, Japan
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Conditions:
Congestive Heart Failure
Ischemic Cardiomyopathy
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
Brief Summary
The aim of this study is to evaluate the safety and efficacy on the transplantation of autologous human cardiac-derived stem cells (hCSCs) with the controlled release of basic fibroblast growth factor...
Detailed Description
Autologous human stem or progenitor cells of different lineage have been subjected to clinical trials in the past to treat patients with ischemic cardiomyopathy. Although human stem or progenitor cell...
Eligibility Criteria
Inclusion
- Clinical diagnosis of ischemic cardiomyopathy
- Ischemic cardiomyopathy with old myocardial infarction due to coronary artery atherosclerotic disease.
- Age: 20 to 80 years old
- left ventricle (LV) dysfunction : An ejection fraction (EF)≧15%, and ≦35% assessed by echocardiography
- Refractory heart failure: American Heart Association (AHA)/American College of Cardiology (ACC)heart failure Stage D
- Heart failure symptom: New York Heart Association (NYHA) Class III or IV
- An indication for CABG:A myocardial ischemia according to major coronary artery stenosis (\>75%)
- Viability in the infarct area as measured by cardiac delayed hyperenhancement magnetic resonance imaging (MRI)
- Infarct area affecting \>2 contiguous LV segments in a 18-segment model
- The number of segments which transmural extent of hyperenhancement 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.
- written informed consent
Exclusion
- New onset of myocardial infarction or unstable angina within 28 days prior to study entry
- Indication for surgical ventricular reconstruction or mitral valve repair \*1
- Contraindication for endomyocardial biopsy \*2
- Evidence for malignant disease within 3 years prior to study entry
- Chronic hemodialysis
- Liver Cirrhosis (ICGR 15 \>30%)
- Uncontrollable diabetes mellitus (HbA1c\>8.0)
- Maximum diameter of Aortic aneurysm more than 5.5 cm.(including dissecting aneurysm)
- Cardiogenic shock
- Active infection (including cytomegalovirus infection)
- Drug or alcoholic dependency
- Positive for HIV antigen
- Active bleeding state (gastric ulcer, cerebral bleeding, etc.)
- Gelatin allergy \*3
- Chromosomal abnormality
- 1 an indication for LV aneurysmectomy; patients with over 2 segments of dyskinesis area
- 2 contra-indication for endomyocardial biopsy
- cardiogenic shock
- end-stage or uncontrollable congestive heart failure without continues infusion of catecholamine
- complete or mobitz type atria-ventricular block
- 3 The screening of gelatin allergy is necessary for all patients by gelatin patch test and gelatin-immunoglobulin E.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00981006
Start Date
April 1 2010
End Date
March 1 2013
Last Update
April 1 2015
Active Locations (2)
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1
Kyoto Prefectural University School of Medicine
Kyoto, Kajii-cho 465, Hirokoji-agaru, Kawaramachi-dori,kamikyoku, Japan, 602-8566
2
National Cardiovascular Center
Osaka, Japan