Transplantation Of Progenitor Cells And Recovery Of Left Ventricular Function In Patients With Nonischemic Dilatative Cardiomyopathy
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Primary Endpoint
- LV function (Ejection fraction within 3 months) Simpson
Study Overview
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 infarction. It is unknown, however, whether such a strategy might also be applicable to patients with non-ischemic dilated cardiomyopathy (DCM). Therefore, we initiated the TOPCARE-DCM - trial (Transplantation Of Progenitor Cells And Recovery of Left Ventricular Function in Patients with non ischemic Dilatative CardioMyopathy) aiming to regionally improve left ventricular contractility by selective infusion of BMC into the left anterior descending coronary artery.
Patients will be randomized 2:1 (20/10) BMC Infusion versus standard medical therapy
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Dilated Cardiomyopathy, Ejection fraction < 40%
- •LVEDD > 60mm
- •Stable clinical condition within last 6 months
- •Written informed consent
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
LV function (Ejection fraction within 3 months) Simpson
Time Frame: 4 months
Secondary Outcomes
No secondary outcomes reported