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

This study has been completed.
Sponsor:
Collaborator:
Hospital Universitario Reina Sofia
Information provided by (Responsible Party):
Iniciativa Andaluza en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT00629096
First received: February 25, 2008
Last updated: May 9, 2013
Last verified: May 2013
  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 2

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:


Further study details as provided by Iniciativa Andaluza en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud:

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 ]

Enrollment: 27
Study Start Date: February 2008
Study Completion Date: December 2010
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:

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

Exclusion Criteria:

  1. Associated coronary artery disease.
  2. Any history or suspicion of a toxic, pharmacologic or deposit etiology.
  3. Absence of resynchronization therapy.
  4. Age longer than 80 years.
  5. Associated malignant or pre-malignant systemic disease.
  6. Associated hematologic disorder.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Spain
Reina Sofía University Hospital
Córdoba, Spain, 14004
Sponsors and Collaborators
Iniciativa Andaluza en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud
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: Iniciativa Andaluza en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud
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: May 9, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Iniciativa Andaluza en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud:
Dilated Cardiomyopathy
Marrow stem cells
Myocardial regeneration
Mesenchymal stem cells
Marrow-derived endothelial progenitor cells

Additional relevant MeSH terms:
Cardiomyopathies
Cardiomyopathy, Dilated
Cardiomegaly
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 25, 2014