Stem Cells and Resynchronization Cardiac

NCT ID: NCT00800657

Last Updated: 2011-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Interventions

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Pacing and Stem Cells Implantations.

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

Intervention Type PROCEDURE

Pacing and Stem Cells Implantation

Pacing and Stem Cells Implantation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Instituto de Molestias Cardiovasculares

OTHER

Sponsor Role lead

Responsible Party

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IMC - Instituto de Moléstias Cardiovasculares

Principal Investigators

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Oswaldo Tadeu Greco, PhD

Role: PRINCIPAL_INVESTIGATOR

IMC - Institute of Hearth Diseases

Oswaldo Tadeu Greco, PhD

Role: PRINCIPAL_INVESTIGATOR

IMC- Institute of Hearth Diseases

Locations

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Imc - Instituto de Moléstias Cardiovasculares

São José do Rio Preto, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Oswaldo Tadeu Greco, PhD

Role: CONTACT

55-17-3203-4000 ext. 4038

Ana Carolina de Abreu, MD

Role: CONTACT

55-17-7811-8477

Facility Contacts

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Oswaldo Tadeu Greco, PhD

Role: primary

55-17-3203-4000 ext. 4038

References

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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.

Reference Type RESULT
PMID: 17874006 (View on PubMed)

Related Links

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http://deca.org.br

Departamento de Estimulação Cardiaca e Arritmia.

Other Identifiers

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HFRCTC1

Identifier Type: -

Identifier Source: secondary_id

HFRCTC1

Identifier Type: -

Identifier Source: org_study_id

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