Cell Therapy in Dilated Cardiomyopathy: Observational Study

Terminated

• Conditions: Cardiomyopathy, Dilated
• Interventions: Other: Cell therapy

• Registration Number: NCT00612911
• Lead Sponsor: Ministry of Health, Brazil

Brief Summary

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

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

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2006-08
• Study Completion: 2007-08
• Status Verified: 2008-01
• Study First Submitted: 2008-01-23
• Study First Submitted QC: 2008-01-29
• Last Update Submitted: 2008-01-29
• Study First Posted: 2008-02-12
• Last Update Posted: 2008-02-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Major group	Cell therapy	Patients with Idiopathic dilated cardiomyopathy

Primary Outcome Measures

Name	Time	Method
echocardiography	2 months

Trial Locations

Locations (1)

INCL - National Institute of Cardiology Laranjeiras; 🇧🇷 Rio de Janeiro, Brazil