Stem Cells and Resynchronization Cardiac (RCT and SCT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Instituto de Molestias Cardiovasculares.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Medtronic
Information provided by:
Instituto de Molestias Cardiovasculares
ClinicalTrials.gov Identifier:
NCT00800657
First received: November 12, 2008
Last updated: June 22, 2011
Last verified: June 2011
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Stem-Cells and Heart Failure in Several Ethiologies. Alternative Indication With Cardiac Resynchronization

Resource links provided by NLM:


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 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Pacing and Stem Cells Implantations.
    Implantation of Cardiac Ressyncrhonization combined with the implantation of Stem Cells Hematopoietics.
    Procedure: Pacing and Stem Cells Implantation
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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   
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

Additional Information:
Publications:
Responsible Party: Oswaldo Tadeu Greco, IMC - Instituto de Moléstias Cardiovasculares
ClinicalTrials.gov Identifier: NCT00800657     History of Changes
Other Study ID Numbers: HFRCTC1, HFRCTC1
Study First Received: November 12, 2008
Last Updated: June 22, 2011
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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 14, 2014