Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy

Instituto de Cardiologia do Rio Grande do Sul30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dilated Cardiomyopathy

Interventions

intramyocardial bone marrow stem cells implantationPROCEDURE

Control group: the patients will be monitored with regular medical visits. Echocardiography: baseline,3,6,9 months. Cardiac NMR at baseline, 3 and 9 months. Interventional group: Bone-marrow was collected from in the anterior-superior iliac crest and mononuclear stem cells were isolated by centrifugation in the density rate Ficoll-Hypaque 1.077 media. Technique - The approach was through a left mini-thoracotomy. Twenty small injections of cellular suspension were directly made through a 21F butterfly needle(total=5ml), in the anterior, lateral, posterior and apical faces of the LV ((average 9.6±2.6 x 10\[7\] cells). After the procedure, the patients were kept in the p.o. for a minimum period of 24hrs. They were released from the hospital in a period that varied from 5-7 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * Episodes of tachycardia or ventricular fibrillation * Severe or moderated mitral insufficiency * Any other valvulopathies * Previous cardiac surgery

Locations (1)

Institute of Cardiology of Rio Grande do Sul / FUC

Porto Alegre, Rio Grande do Sul, Brazil

Outcomes

Primary Outcomes

Increase of the ejection function of the left ventricle

Time frame: twelve months

Data from ClinicalTrials.gov

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