Clinical trial NCT00284713: Progenitor Cell Therapy in Dilative Cardiomyopathy
Official title: Transplantation Of Progenitor Cells And Recovery Of Left Ventricular Function In Patients With Nonischemic Dilatative Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Heart Failure, Congestive
Cardiomyopathy, Dilated
Stem Cell Transplantation
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2006-02-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: LV function (Ejection fraction within 3 months) Simpson
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Div. of Cardiology, University of Frankfurt, Germany
name: Andreas M Zeiher
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Rosa S, Seeger FH, Honold J, Fischer-Rasokat U, Lehmann R, Fichtlscherer S, Schachinger V, Dimmeler S, Zeiher AM, Assmus B. Procedural safety and predictors of acute outcome of intracoronary administration of progenitor cells in 775 consecutive procedures performed for acute myocardial infarction or chronic heart failure. Circ Cardiovasc Interv. 2013 Feb;6(1):44-51. doi: 10.1161/CIRCINTERVENTIONS.112.971705. Epub 2013 Jan 29.
citation: Leistner DM, Seeger FH, Fischer A, Roxe T, Klotsche J, Iekushi K, Seeger T, Assmus B, Honold J, Karakas M, Badenhoop K, Frantz S, Dimmeler S, Zeiher AM. Elevated levels of the mediator of catabolic bone remodeling RANKL in the bone marrow environment link chronic heart failure with osteoporosis. Circ Heart Fail. 2012 Nov;5(6):769-77. doi: 10.1161/CIRCHEARTFAILURE.111.966093. Epub 2012 Aug 30.
citation: Xu Q, Seeger FH, Castillo J, Iekushi K, Boon RA, Farcas R, Manavski Y, Li YG, Assmus B, Zeiher AM, Dimmeler S. Micro-RNA-34a contributes to the impaired function of bone marrow-derived mononuclear cells from patients with cardiovascular disease. J Am Coll Cardiol. 2012 Jun 5;59(23):2107-17. doi: 10.1016/j.jacc.2012.02.033.