Stem Cells and Resynchronization Cardiac - Full Text View

Sponsors and Collaborators:	Instituto de Molestias Cardiovasculares Medtronic
Information provided by:	Instituto de Molestias Cardiovasculares
ClinicalTrials.gov Identifier:	NCT00800657

Purpose

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.

Condition	Intervention	Phase
Heart Failure	Procedure: Pacing and Stem Cells Implantations. Procedure: Pacing and Stem Cells Implantation	Phase I

MedlinePlus related topics: Cardiomyopathy Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Single Blind (Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Stem-Cells and Heart Failure in Several Ethiologies. Alternative Indication With Cardiac Resynchronization

Further study details as provided by Instituto de Molestias Cardiovasculares:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Ejection Fraction (Echo/Sympson) and functional class(NYHA). [ Time Frame: 24 months. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Implantation of Cardiac Ressyncrhonization combined with the implantation of Stem Cells Hematopoietics.

Pacing and Stem Cells Implantation.

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800657

Contacts

Contact: Oswaldo Tadeu Greco, PhD	55-17-3203-4000 ext 4038	oswaldogreco@terra.com.br
Contact: Ana Carolina de Abreu, MD	55-17-7811-8477	carolina.cpc@terra.com.br

Locations

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

Sponsors and Collaborators

Instituto de Molestias Cardiovasculares

Medtronic

Investigators

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

More Information

Departamento de Estimulação Cardiaca e Arritmia. This link exits the ClinicalTrials.gov site

IMC-Instituto de Moléstias Cardiovasculares This link exits the ClinicalTrials.gov site

Publications of Results:

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. English, Portuguese.

Responsible Party:	IMC - Instituto de Moléstias Cardiovasculares ( Oswaldo Tadeu Greco )
Study ID Numbers:	HFRCTC1, HFRCTC1
Study First Received:	November 12, 2008
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00800657
Health Authority:	Brazil: Ethics Committee

Keywords provided by Instituto de Molestias Cardiovasculares:

Cardiac Resynchronization
Dilated Cardiomyopathy
Stem Cells Therapy
Heart Failure
Stem Cells/Cardiac Pacing, Artificial

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Cardiomyopathy, Dilated
Dilated cardiomyopathy
Cardiomyopathies

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009