Stem Cells and Resynchronization Cardiac (RCT and SCT)

Instituto de Molestias Cardiovasculares

Status and phase: Unknown; Phase 1

Conditions: Heart Failure

Treatments: Procedure: Pacing and Stem Cells Implantation; Procedure: Pacing and Stem Cells Implantations.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00800657

HFRCTC1

Details and patient eligibility

About

Same patients with dilated myocardiopathies with large areas of fibrosis has not been as successful after Cardiac Resynchronization Therapy, for Heart Failure patients in functional class III or IV. Therefore the investigators have decided to associate the Stem-Cell implant with Cardiac Resynchronization Therapy in these patients.

Full description

About 120cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution the mononuclear cells are injected into the cardiac muscles with fibroses area through 20 shots.This procedure is indicated for patients with cardiac ischemia and left ventricular dysfunction(desynchrony), on whom all the others known therapies have failed.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• Dilated Cardiomyopathy
• Heart Failure
• Optimized Therapeutics
• Ventricular Desynchrony
• Functional Class III or IV
• Ejection Fraction(Echo/ Sympson) < 35%

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind