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

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Dilated cardiomyopathy
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Brief Title

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

Official Title

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.

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

safety: morbidity/mortality

Condition

Dilated Cardiomyopathy

Intervention

intramyocardial bone marrow stem cells implantation

Publications

* 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

Procedure

Estimated Enrollment

6

Start Date

April 2004

Completion Date

December 2006

Primary Completion Date

October 2006

Eligibility Criteria

        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

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations

NCT ID

NCT00615394

Organization ID

UP3549/04

Study Sponsor

Instituto de Cardiologia do Rio Grande do Sul

Collaborators

 Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Study Sponsor

, ,

Verification Date

February 2008