Cell Therapy in Dilated Cardiomyopathy: Observational Study

Ministry of Health, Brazil

Status: Terminated

Conditions: Cardiomyopathy, Dilated

Treatments: Other: Cell therapy

Study type: Observational

Funder types: Other

Identifiers

NCT00612911

CTDil-1

Details and patient eligibility

About

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

Full 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

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

24 participants in 1 patient group

Major group

Description:

Patients with Idiopathic dilated cardiomyopathy

Treatment:

Other: Cell therapy