Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy in Dilated Cardiomyopathy - Technique and Early Results

Instituto de Cardiologia do Rio Grande do Sul1 site in 1 country6 target enrollmentApril 2004

ConditionsDilated Cardiomyopathy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Dilated Cardiomyopathy
Sponsor: Instituto de Cardiologia do Rio Grande do Sul
Enrollment: 6
Locations: 1
Primary Endpoint: safety: morbidity/mortality
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Bone marrow mononuclear cells (BMMC) transplantation is a promising therapy for treating ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.This study describes a technique of BMMC transplantation utilizing mini-thoracotomy and results up to one year after the procedure.

Registry

clinicaltrials.gov

Start Date

April 2004

End Date

December 2006

Last Updated

18 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 two years 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 60 years
•absence of neoplasm
•absence of hematologic disease or systemic disease
•no previous cardiac intervention