Stem Cells and Resynchronization Cardiac

Heart Failure Clinical Trial

— RCT and SCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00800657
• Other study ID #: HFRCTC1
• Secondary ID: HFRCTC1
• Status: Recruiting
• Phase: Phase 1
• First received: November 12, 2008
• Last updated: June 22, 2011
• Start date: November 2008
• Est. completion date: December 2011

Study information

• Verified date: June 2011
• Source: Instituto de Molestias Cardiovasculares
• Contact: Oswaldo Tadeu Greco, PhD
• Phone: 55-17-3203-4000
• Email: oswaldogreco[@]terra.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

• Dilated Cardiomyopathy

• Heart Failure

• Optimized Therapeutics

• Ventricular Desynchrony

• Functional Class III or IV

• Ejection Fraction(Echo/ Sympson) < 35%

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• Pacing and Stem Cells Implantations.
Implantation of Cardiac Ressyncrhonization combined with the implantation of Stem Cells Hematopoietics.
• Pacing and Stem Cells Implantation
Pacing and Stem Cells Implantation.

Locations

Country	Name	City	State
Brazil	Imc - Instituto de Moléstias Cardiovasculares	São José do Rio Preto	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Molestias Cardiovasculares	Medtronic

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		24 months	Yes
Secondary	Ejection Fraction (Echo/Sympson) and functional class(NYHA).		24 months.	Yes

External Links

•   Departamento de Estimulação Cardiaca e Arritmia.
•   IMC-Instituto de Moléstias Cardiovasculares