Progenitor Cell Therapy in Dilative Cardiomyopathy

Transplantation Of Progenitor Cells And Recovery Of Left Ventricular Function In Patients With Nonischemic Dilatative Cardiomyopathy

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00284713

Enrollment

Registered

2006-02-01

Start date

2004-05-31

Completion date

2009-01-31

Last updated

2009-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy, Dilated, Heart Failure, Congestive, Stem Cell Transplantation

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

Interventions

PROCEDUREintracoronary infusion of BMC

catheter delivery of stem cells

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Age 8-80 * 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

Design outcomes

Primary

Measure	Time frame
LV function (Ejection fraction within 3 months) Simpson	4 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026