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Cell Therapy in Dilated Cardiomyopathy: Observational Study

Cell Therapy in Dilated Cardiomyopathy: A Safety and Feasibility Study Using Autologous Bone Marrow Mononuclear Cells

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00612911
Enrollment
24
Registered
2008-02-12
Start date
2005-02-28
Completion date
2007-08-31
Last updated
2008-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy, Dilated

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

Interventions

OTHERCell therapy

bone marrow mononuclear cell

Sponsors

Ministry of Health, Brazil
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
echocardiography2 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026