Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy (SDILCM)

Instituto de Cardiologia do Rio Grande do Sul

Status and phase: Completed; Phase 3; Phase 2

Conditions: Dilated Cardiomyopathy

Treatments: Procedure: intramyocardial bone marrow stem cells implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00743639

UP3758

Details and patient eligibility

About

This study describes a controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem-cell implants by minithoracotomy in patients with dilated cardiomyopathy and cardiac failure class III or NYHA.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis made at more than one year and symptomatic at functional class III-IV by the New York Heart Association classification (NYHA) despite optimal pharmacologic therapy
• Left ventricular ejection fraction (LVEF) less than 35% by echocardiogram
• Age below 70 years
• Absence of neoplasm
• Abscence of hematologic disease or systemic disease
• No previous cardiac intervention

Exclusion criteria

• Episodes of tachycardia or ventricular fibrillation
• Severe or moderated mitral insufficiency
• Any other valvulopathies
• Previous cardiac surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

1

Other group

Description:

Interventional

Treatment:

Procedure: intramyocardial bone marrow stem cells implantation