Suspended

Cell Therapy in Dilated Cardiomyopathy: A Safety and Feasibility Study Using Autologous Bone Marrow Mononuclear Cells

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Laminopathies+5

+ Cardiomyopathy, Dilated

+ Cardiovascular Diseases

From 18 to 70 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: February 2005
See protocol details

Summary

Principal SponsorMinistry of Health, Brazil
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2005

Actual date on which the first participant was enrolled.

Patients with Idiopathic dilated cardiomyopathy class II to IV NYHA with ejection fraction <35% were selected for phase I clinical trial of bone marrow mononuclear cell delivery in the coronary arteries and followed for 6 months

Official TitleCell Therapy in Dilated Cardiomyopathy: A Safety and Feasibility Study Using Autologous Bone Marrow Mononuclear Cells
NCT00612911
Principal SponsorMinistry of Health, Brazil
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

LaminopathiesCardiomyopathy, DilatedCardiovascular DiseasesHeart DiseasesCardiomegalyCardiomyopathiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Criteria

5 inclusion criteria required to participate
Left ventricular ejection fraction (Simpson) < 35%
Peak oxygen consumption (VO2 peak) < 16 mL.kg-1min-1
Functional classes II-IV of the NYHA
Diagnosis of idiopathic dilated cardiomyopathy
Show More Criteria
6 exclusion criteria prevent from participating
pregnancy
dilated cardiopathies of ischemic or chagasic origin
primary valve disease
excessive use of alcohol or illicit drugs
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

INCL - National Institute of Cardiology Laranjeiras

Rio de Janeiro, BrazilOpen INCL - National Institute of Cardiology Laranjeiras in Google Maps
SuspendedOne Study Center