Intracoronary Infusion of Autologous Bone Marrow Cells for Treatment of Idiopathic Dilated Cardiomyopathy
This study has been completed.
Sponsor:
Fundación Pública Andaluza Progreso y Salud
Collaborator:
Hospital Universitario Reina Sofia
Information provided by (Responsible Party):
Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT00629096
First received: February 25, 2008
Last updated: May 9, 2013
Last verified: May 2013
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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:
- To evaluate possible changes in patient functional capacity and
- 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:
Genetics Home Reference related topics:
DMD-associated dilated cardiomyopathy
MedlinePlus related topics:
Cardiomyopathy
U.S. FDA Resources
Further study details as provided by 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:
- 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
Locations
| Spain | |
| Reina Sofía University Hospital | |
| Córdoba, Spain, 14004 | |
Sponsors and Collaborators
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: | 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 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:
|
Cardiomyopathy, Dilated Cardiomyopathies Cardiomegaly Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013