Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy - Full Text View

Sponsors and Collaborators:	Instituto de Cardiologia do Rio Grande do Sul FAPERGS CNPq
Information provided by:	Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier:	NCT00743639

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 II Phase III

MedlinePlus related topics: Bone Grafts Bone Marrow Transplantation Cardiomyopathy

Drug Information available for: Amidotrizoic Acid Diatrizoate Diatrizoate meglumine Diatrizoate Sodium BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy: Randomized Clinical Trial

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.

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, Rio Grande do Sul
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

FAPERGS

CNPq

Investigators

Study Director:

Renato AK Kalil, MD, PhD

Institute of Cardiology of Rio Grande do Sul / FUC

More Information

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

Keywords provided by Instituto de Cardiologia do Rio Grande do Sul:

Cardiomyopathy
stem cell
cardiac failure

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Cardiomyopathy, Dilated

Dilated cardiomyopathy
Cardiomegaly
Cardiomyopathies

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009