Stem-Cells and Heart Failure in Several Ethiologies. Alternative Indication With Cardiac Resynchronization
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Ejection Fraction(EF)-(Eco- Sympson):It is the comparison of these measurements between late pre and post operative. NYHA: Comparison of these measurements between late pre and post operative.
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Dilated Cardiomyopathy
- •Heart Failure
- •Optimized Therapeutics
- •Ventricular Desynchrony
- •Functional Class III or IV
- •Ejection Fraction(Echo/ Sympson) < 35%
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Ejection Fraction(EF)-(Eco- Sympson):It is the comparison of these measurements between late pre and post operative. NYHA: Comparison of these measurements between late pre and post operative.
Time Frame: 24 months
Secondary Outcomes
- Ejection Fraction (Echo/Sympson) and functional class(NYHA).(24 months.)