Stem Cells and Resynchronization Cardiac (RCT and SCT)

June 22, 2011 updated by: Instituto de Molestias Cardiovasculares

Stem-Cells and Heart Failure in Several Ethiologies. Alternative Indication With Cardiac Resynchronization

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.

Study Overview

Status

Unknown

Conditions

Heart Failure

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Brazil
- São Paulo
  - São José do Rio Preto, São Paulo, Brazil, 15015-210
    - Recruiting
    - Imc - Instituto de Moléstias Cardiovasculares
    - Contact:
      
      Oswaldo Tadeu Greco, PhD
      
      Phone Number: 4038 55-17-3203-4000
      
      Email: oswaldogreco@terra.com.br
    - Principal Investigator:
      
      Oswaldo Tadeu Greco, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Ejection Fraction (Echo/Sympson) and functional class(NYHA). Time Frame: 24 months.	24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Molestias Cardiovasculares

Collaborators

Medtronic

Investigators

Principal Investigator: Oswaldo Tadeu Greco, PhD, IMC - Institute of Hearth Diseases
Principal Investigator: Oswaldo Tadeu Greco, PhD, IMC- Institute of Hearth Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Jacob JL, Salis FV, Ruiz MA, Greco OT. Labeled stem cells transplantation to the myocardium of a patient with Chagas' disease. Arq Bras Cardiol. 2007 Aug;89(2):e10-1. doi: 10.1590/s0066-782x2007001400014. English, Portuguese.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)