Cell Therapy in Dilated Cardiomyopathy: Observational Study

Overview

Using bone marrow mononuclear cell in 24 patients with Idiopathic dilated cardiomyopathy

Full Title of Study: “Cell Therapy in Dilated Cardiomyopathy: A Safety and Feasibility Study Using Autologous Bone Marrow Mononuclear Cells”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2006

Detailed Description

Patients with Idiopathic dilated cardiomyopathy class II to IV NYHA with ejection fraction <35% were selected for phase I clinical trial of bone marrow mononuclear cell delivery in the coronary arteries and followed for 6 months

Interventions

  • Other: Cell therapy
    • bone marrow mononuclear cell

Arms, Groups and Cohorts

  • Major group
    • Patients with Idiopathic dilated cardiomyopathy

Clinical Trial Outcome Measures

Primary Measures

  • echocardiography
    • Time Frame: 2 months

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of idiopathic dilated cardiomyopathy – Optimized therapy and for idiopathic dilated cardiomyopathy – Left ventricular ejection fraction (Simpson) < 35% – Peak oxygen consumption (VO2 peak) < 16 mL.kg-1min-1 – Functional classes II-IV of the NYHA Exclusion Criteria:

  • dilated cardiopathies of ischemic or chagasic origin – primary valve disease – excessive use of alcohol or illicit drugs – pregnancy – ventricular arrhythmias – any co-morbidity with impact on survival

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ministry of Health, Brazil
  • Provider of Information About this Clinical Study
    • Helena Martino, Brazil: National Institute of Cardioloy
  • Overall Official(s)
    • Helena F Martino, Principal Investigator, Brazil: National Insittute of Cardiology

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