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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