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

August 28, 2008 updated by: Instituto de Cardiologia do Rio Grande do Sul

Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy: Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90620001
        • Institute of Cardiology of Rio Grande do Sul / FUC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase of the ejection function of the left ventricle
Time Frame: twelve months
twelve months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Cardiologia do Rio Grande do Sul

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

August 28, 2008

First Submitted That Met QC Criteria

August 28, 2008

First Posted (Estimate)

August 29, 2008

Study Record Updates

Last Update Posted (Estimate)

August 29, 2008

Last Update Submitted That Met QC Criteria

August 28, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UP3758

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe