Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy: Randomized Clinical Trial

Instituto de Cardiologia do Rio Grande do Sul1 site in 1 country30 target enrollmentJuly 2005

ConditionsDilated Cardiomyopathy

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Dilated Cardiomyopathy
Sponsor: Instituto de Cardiologia do Rio Grande do Sul
Enrollment: 30
Locations: 1
Primary Endpoint: Increase of the ejection function of the left ventricle
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study describes a controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem-cell implants by minithoracotomy in patients with dilated cardiomyopathy and cardiac failure class III or NYHA.

Registry

clinicaltrials.gov

Start Date

July 2005

End Date

June 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Instituto de Cardiologia do Rio Grande do Sul

Eligibility Criteria

Inclusion Criteria

•Diagnosis made at more than one year and symptomatic at functional class III-IV by the New York Heart Association classification (NYHA) despite optimal pharmacologic therapy
•Left ventricular ejection fraction (LVEF) less than 35% by echocardiogram
•Age below 70 years
•Absence of neoplasm
•Abscence of hematologic disease or systemic disease
•No previous cardiac intervention