Status:
COMPLETED
Progenitor Cell Therapy in Dilative Cardiomyopathy
Lead Sponsor:
Johann Wolfgang Goethe University Hospital
Conditions:
Heart Failure, Congestive
Cardiomyopathy, Dilated
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Intracoronary infusion of bone marrow derived progenitor cells into the LAD in patients with non ischemic dilated cardiomyopathy.
Detailed Description
Initial clinical pilot trials suggested that intracoronary infusion of bone marrow-derived progenitor cells (BMC) may enhance left ventricular functional recovery in patients with acute myocardial inf...
Eligibility Criteria
Inclusion
- Age 8-80
- Dilated Cardiomyopathy, Ejection fraction \< 40%
- LVEDD \> 60mm
- Stable clinical condition within last 6 months
- Written informed consent
Exclusion
- Myocardial infarction or coronary intervention in the past
- Change of medical therapy within the last 6 weeks prior to cell therapy
- Tumor within last 5 years or incomplete remission
- Active infection
- Active bleeding
- Stroke within last 2 years
- Surgery or trauma within last 2 months
- Uncontrolled hypertension
- HIV infection
- Chronic inflammatory disease
- Liver disease (GOT \> 2x upper normal limit)
- Renal dysfunction (creatinin \> 2.0mg/dl)
- Thrombopenia \< 100.000
- Anemia (hemoglobin \< 8.5 g/dl)
- Mental retardation
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00284713
Start Date
May 1 2004
End Date
January 1 2009
Last Update
February 18 2009
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