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

Instituto de Cardiologia do Rio Grande do Sul

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dilated Cardiomyopathy

Treatments: Procedure: intramyocardial bone marrow stem cells implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00615394

UP3549/04

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)