Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy

Phase 1

Completed

• Conditions: Dilated Cardiomyopathy

• Registration Number: NCT00615394
• Lead Sponsor: Instituto de Cardiologia do Rio Grande do Sul

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2006-10
• Study Completion: 2006-12
• Status Verified: 2008-02
• Study First Submitted: 2008-02-01
• Study First Submitted QC: 2008-02-01
• Last Update Submitted: 2008-02-01
• Study First Posted: 2008-02-14
• Last Update Posted: 2008-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Exclusion Criteria

• episodes of tachycardia or ventricular fibrillation
• severe or moderated mitral insufficiency
• any other valvulopathies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
safety: morbidity/mortality	eighteen months

Trial Locations

Locations (1)

Instituto de Cardiologia do Rio Grande do Sul; 🇧🇷 Porto Alegre, RS, Brazil