Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy - Tabular View

Tracking Information
First Received Date ^ICMJE	February 1, 2008
Last Updated Date	February 1, 2008
Start Date ^ICMJE	April 2004
Primary Completion Date	October 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 1, 2008)	safety: morbidity/mortality [ Time Frame: eighteen months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy
Official Title ^ICMJE	Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy in Dilated Cardiomyopathy - Technique and Early Results
Brief Summary	Bone marrow mononuclear cells (BMMC) transplantation is a promising therapy for treating ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.This study describes a technique of BMMC transplantation utilizing mini-thoracotomy and results up to one year after the procedure.
Detailed Description
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Dilated Cardiomyopathy
Intervention ^ICMJE	Procedure: intramyocardial bone marrow stem cells implantation
Study Arms / Comparison Groups
Publications *	Kalil RA, Ott D, Sant'Anna R, Dias E, Marques-Pereira JP, Delgado-Cañedo A, Nardi NB, Sant'Anna JR, Prates PR, Nesralla I. Autologous transplantation of bone marrow mononuclear stem cells by mini-thoracotomy in dilated cardiomyopathy: technique and early results. Sao Paulo Med J. 2008 Mar 6;126(2):75-81.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	6
Completion Date	December 2006
Primary Completion Date	October 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: diagnosis made at more than two years 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 60 years absence of neoplasm absence 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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Brazil

Administrative Information
NCT ID ^ICMJE	NCT00615394
Responsible Party	Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia
Study ID Numbers ^ICMJE	UP3549/04
Study Sponsor ^ICMJE	Instituto de Cardiologia do Rio Grande do Sul
Collaborators ^ICMJE	FAPERGS CNPq
Investigators ^ICMJE
Information Provided By	Instituto de Cardiologia do Rio Grande do Sul
Verification Date	February 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP