NCT00629096

Brief Summary

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. 1.To evaluate possible changes in patient functional capacity and
  2. 2.to identify the biological characteristics of the bone marrow graft that might influence on functional recovery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 5, 2014

Status Verified

May 1, 2013

Enrollment Period

2.5 years

First QC Date

February 25, 2008

Last Update Submit

December 4, 2014

Conditions

Dilated Cardiomyopathy

Keywords

Dilated CardiomyopathyMarrow stem cellsMyocardial regenerationMesenchymal stem cellsMarrow-derived endothelial progenitor cells

Outcome Measures

Primary Outcomes (1)

  • Improvement of left ventricular function

    6 and 12 months

Secondary Outcomes (1)

  • Functional status

    6 and 12 months

Study Arms (1)

1

EXPERIMENTAL

All included patients are assigned to arm 1, in which they are treated by the intervention

Procedure: Intracoronary infusion of autologous bone marrow cells

Interventions

Intracoronary infusion of autologous bone marrow cellsPROCEDURE

Autologous mononuclear bone marrow cells will be administered by intracoronary infusion via a percutaneous catheter

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reina Sofía University Hospital

Córdoba, Córdoba, 14004, Spain

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jose Suarez de Lezo, MD, PhD

    Department of Cardiology. Reina Sofía University Hospital

    STUDY CHAIR

  • I. Concepción Herrera, MD, PhD

    Department of Hematology.Reina Sofia University Hospital

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2008

First Posted

March 5, 2008

Study Start

February 1, 2008

Primary Completion

August 1, 2010

Study Completion

December 1, 2010

Last Updated

December 5, 2014

Record last verified: 2013-05

Locations

ES(1)