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
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:
Cardiomyopathy, Dilated
Cardiomyopathies
Cardiomegaly
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014