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Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy (SDILCM)

This study has been completed.
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT00743639
First received: August 28, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

This study describes a controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem-cell implants by minithoracotomy in patients with dilated cardiomyopathy and cardiac failure class III or NYHA.


Condition Intervention Phase
Dilated Cardiomyopathy
Procedure: intramyocardial bone marrow stem cells implantation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy: Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Instituto de Cardiologia do Rio Grande do Sul:

Primary Outcome Measures:
  • Increase of the ejection function of the left ventricle [ Time Frame: twelve months ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: July 2005
Study Completion Date: June 2008
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Interventional
Procedure: intramyocardial bone marrow stem cells implantation

Control group: the patients will be monitored with regular medical visits. Echocardiography: baseline,3,6,9 months. Cardiac NMR at baseline, 3 and 9 months.

Interventional group: Bone-marrow was collected from in the anterior-superior iliac crest and mononuclear stem cells were isolated by centrifugation in the density rate Ficoll-Hypaque 1.077 media. Technique - The approach was through a left mini-thoracotomy. Twenty small injections of cellular suspension were directly made through a 21F butterfly needle(total=5ml), in the anterior, lateral, posterior and apical faces of the LV ((average 9.6±2.6 x 10[7] cells). After the procedure, the patients were kept in the p.o. for a minimum period of 24hrs. They were released from the hospital in a period that varied from 5-7 days.


  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis made at more than one year and symptomatic at functional class III-IV by the New York Heart Association classification (NYHA) despite optimal pharmacologic therapy
  • Left ventricular ejection fraction (LVEF) less than 35% by echocardiogram
  • Age below 70 years
  • Absence of neoplasm
  • Abscence of hematologic disease or systemic disease
  • No previous cardiac intervention

Exclusion Criteria:

  • Episodes of tachycardia or ventricular fibrillation
  • Severe or moderated mitral insufficiency
  • Any other valvulopathies
  • Previous cardiac surgery
  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: NCT00743639

Locations
Brazil
Institute of Cardiology of Rio Grande do Sul / FUC
Porto Alegre, Rio Grande do Sul, Brazil, 90620001
Sponsors and Collaborators
Instituto de Cardiologia do Rio Grande do Sul
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Study Director: Renato AK Kalil, MD, PhD Institute of Cardiology of Rio Grande do Sul / FUC
  More Information

No publications provided

Responsible Party: James Fracasso, Instituto de Cardiologia do Rio Grande do Sul / Fund. Universit. Cardiologia
ClinicalTrials.gov Identifier: NCT00743639     History of Changes
Other Study ID Numbers: UP3758
Study First Received: August 28, 2008
Last Updated: August 28, 2008
Health Authority: Brazil: Ethics Committee

Keywords provided by Instituto de Cardiologia do Rio Grande do Sul:
Cardiomyopathy
stem cell
cardiac failure

Additional relevant MeSH terms:
Cardiomyopathies
Cardiomyopathy, Dilated
Cardiomegaly
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 23, 2014