Intracoronary Infusion of Autologous Bone Marrow Cells for Treatment of Idiopathic Dilated Cardiomyopathy

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2008 by Hospital Universitario Reina Sofia. Recruitment status was Recruiting

First Received on February 25, 2008. Last Updated on March 4, 2008 History of Changes

Sponsor:	Hospital Universitario Reina Sofia
Information provided by:	Hospital Universitario Reina Sofia
ClinicalTrials.gov Identifier:	NCT00629096

Purpose

The main aim of the study is to determine whether intracoronary infusion of autologous bone marrow mononuclear cells can improve the ventricular function of patients with idiopathic dilated cardiomyopathy.Secondary end-points will be:1)To evaluate possible changes in patient functional capacity and 2)to identify the biological characteristics of the bone marrow graft that might influence on functional recovery.

Condition	Intervention	Phase
Dilated Cardiomyopathy	Procedure: Intracoronary infusion of autologous bone marrow cells	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effects of Intracoronary Infusion of Bone Marrow-Derived Progenitor Cells on Myocardial Regeneration in Patients With Non-Ischemic Dilated Cardiomyopathy.

Resource links provided by NLM:

MedlinePlus related topics: Cardiomyopathy

U.S. FDA Resources

Further study details as provided by Hospital Universitario Reina Sofia:

Primary Outcome Measures:

Improvement of left ventricular function [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Functional status [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	February 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 All included patients are assigned to arm 1, in which they are treated by the intervention	Procedure: Intracoronary infusion of autologous bone marrow cells Autologous mononuclear bone marrow cells will be administered by intracoronary infusion via a percutaneous catheter

Show Detailed Description

Eligibility

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

Criteria

Inclusion Criteria:

Patients of both genders with established clinical and angiographic diagnosis of Idiopathic Dilated Cardiomyopathy who accept to participate in the trial.
They should have symptoms and/or signs of heart failure, despite optimized medical treatment.
Angiographic ejection fraction should be less than 50%.

Exclusion Criteria:

Associated coronary artery disease.
Any history or suspicion of a toxic, pharmacologic or deposit etiology.
Absence of resynchronization therapy.
Age longer than 80 years.
Associated malignant or pre-malignant systemic disease.
Associated hematologic disorder.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629096

Contacts

Contact: Jose Suarez de Lezo, MD, PhD	34-957010438	jsuarezdelezo@infonegocio.com
Contact: I.Concepción Herrera, MD,PhD	34-957012965	inmaculada.herrera.sspa@juntadeandalucia.es

Locations

Spain
Reina Sofía University Hospital	Recruiting
Córdoba, Spain, 14004

Sponsors and Collaborators

Hospital Universitario Reina Sofia

Investigators

Study Chair:	Jose Suarez de Lezo, MD, PhD	Department of Cardiology. Reina Sofía University Hospital
Study Director:	I. Concepción Herrera, MD, PhD	Department of Hematology.Reina Sofia University Hospital
Principal Investigator:	Manuel Pan, MD, PhD	Department of Cardiology. Reina sofia University Hospital
Principal Investigator:	Jose Maria Arizon, MD	Department of Cardiology. Reina Sofía university Hospital
Principal Investigator:	Miguel Angel Romero, MD, PhD	Department of Cardiology. Reina Sofía University Hospital
Principal Investigator:	Ramon Ribes, MD, PhD	Department of Radiology. Reina Sofía University Hospital
Principal Investigator:	Joaquin Sanchez, MD, PhD	Department of Hematology. Reina Sofía Unuversity Hospital
Principal Investigator:	Antonio Torrers, MD, PhD	Department of Hematology. Reina Sofía University Hospital

More Information

No publications provided

Responsible Party:	Jose Suarez de Lezo, Hospital Universitario Reina Sofia
ClinicalTrials.gov Identifier:	NCT00629096 History of Changes
Other Study ID Numbers:	TCMR0007/2006, EudraCT 2007-003088-36
Study First Received:	February 25, 2008
Last Updated:	March 4, 2008
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitario Reina Sofia:

Dilated Cardiomyopathy
Marrow stem cells
Myocardial regeneration
Mesenchymal stem cells
Marrow-derived endothelial progenitor cells

Additional relevant MeSH terms:

Cardiomyopathy, Dilated
Cardiomyopathies
Cardiomegaly
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012