Progenitor Cell Therapy in Dilative Cardiomyopathy - Full Text View

Purpose

Intracoronary infusion of bone marrow derived progenitor cells into the LAD in patients with non ischemic dilated cardiomyopathy.

Condition	Intervention	Phase
Heart Failure, Congestive Cardiomyopathy, Dilated Stem Cell Transplantation	Procedure: intracoronary infusion of BMC	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Transplantation Of Progenitor Cells And Recovery Of Left Ventricular Function In Patients With Nonischemic Dilatative Cardiomyopathy

Resource links provided by NLM:

Genetics Home Reference related topics: DMD-associated dilated cardiomyopathy

MedlinePlus related topics: Cardiomyopathy Heart Failure

U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:

LV function (Ejection fraction within 3 months) Simpson [ Time Frame: 4 months ]

Estimated Enrollment:	30
Study Start Date:	May 2004
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

catheter delivery of stem cells

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284713

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospitals

Investigators

Principal Investigator:

Andreas M Zeiher

Div. of Cardiology, University of Frankfurt, Germany

More Information

No publications provided by Johann Wolfgang Goethe University Hospitals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

De Rosa S, Seeger FH, Honold J, Fischer-Rasokat U, Lehmann R, Fichtlscherer S, Schächinger 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.

Leistner DM, Seeger FH, Fischer A, Röxe 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.

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.

ClinicalTrials.gov Identifier:	NCT00284713 History of Changes
Other Study ID Numbers:	TOPCARE-DCM
Study First Received:	January 31, 2006
Last Updated:	February 17, 2009
Health Authority:	Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:

Cardiomyopathy, Dilated
Heart Failure
Cardiomyopathies

Cardiomegaly
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013