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Meta-analysis of Cardiac Stem Cell Studies (MESS)

This study is currently recruiting participants.
Verified June 2012 by Medical University of Vienna
Sponsor:
Collaborators:
Hannover Medical School
IRT-Universite de Nantes France
Rikshospitalet University Hospital
Medical University of Silesia
Leiden University Medical Center
University of Novosibirsk Russia
Rigshospitalet, Denmark
University of Skopje
Asklepios Kliniken Hamburg GmbH
University of Debrecen
University Hospital of Targu Mures, Romania
Information provided by (Responsible Party):
Mariann Gyongyosi, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01098591
First received: March 30, 2010
Last updated: June 10, 2012
Last verified: June 2012
History of Changes
  Purpose

Numerous human cardiac stem cell studies have been published, including relatively small number of patients. Meta-analysis of randomized trials have reported safety and a 3-6% increase in global left ventricular performance after intracoronary stem cell therapy in patients with acute myocardial infarction. Since most of the studies used different type of stem cells, delivery modes, and patient population, the results are heterogenous, therefore the comparison of the results is biased regarding generalizable conclusions about the effect of treatment. The present comparative meta-analysis is based on individual patient data, and gathers and pools the raw data, and analyzes the clinical outcome, safety and efficacy of the cardiac stem cell therapy.


Condition
Ischemic Heart Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Meta-analysis of European Human Cardiac Stem Cell Studies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Left ventricular ejection fraction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change of global left ventricular funtion 3-6 month after cardiac stem cell therapy


Secondary Outcome Measures:
  • Infarct size [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Decrease of infarct size 3-6 months after cardiac stem cell therapy

  • Canadian Cardiovascular Society (CCS) Classification of angina pectoris [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement of clinical angina status

  • Major adverse cardiac and cerebrovascular events (MACCE) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Occurrence of major adverse cardiac and cerebrovascular events after cardiac stem cell therapy

  • New York Heart Association (NYHA) Functional Classification of Heart Insufficiency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement of NYHA 3-6 months after cardiac stem cell therapy


Estimated Enrollment: 1000
Study Start Date: November 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Myocardial infarction
Patients with post-myocardial infarction receiving cardiac stem cell therapy
Ischemic cardiomyopathy
Patients with ischemic cardiomyopathy treated with cardiac stem cell therapy

Detailed Description:
  • Background: Many clinical trials and meta-analyses presented moderate but significant improvement of the left ventricular ejection fraction (LVEF) after intracoronary autologous bone-marrow (BM) or peripheral blood origin stem cells transfer. However, it remains controversial, whether this beneficial effects is comparable with the intramyocardial delivery of the stem cells, or could be maintained during moderate and long term follow-up. The BOOST trial suggested that cardiac stem cell therapy did not improve LVEF at 5-year follow-up. By contrast, BALANCE study showed a long sustained benefit of BM-stem cells treatment. Due to these divergent outcomes of the presented trials, the aim of the present meta-analysis is to compare the safety and effectiveness of the cardiac stem cell therapy in different patient population, delivery mode and cell type, to find out, which patients with which therapy mode can have the greatest benefit from cardiac stem cell therapy.
  • Study design: individual patient data meta-analysis
  • Data sources: European Centre performing human cardiac stem cell therapy have been contacted calling for participation.
  • Methods: Individual data gathering and entering into the database for a pooled analysis. The meta-analysis will be done in line with recommendation from the Cochrane Collaboration and the Quality of Reporting of Meta-analyses guidelines with Review Manager 5.0. Random-effect model will be used due to the difference of patients' age, stem cell dosage, delivery modes, follow-up duration and time to transplantation among included trials. Heterogeneity of treatment effect will be diagnosed by the use of the Cochrane's Q-test.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients treated with cardiac stem cell therapy at one of the participating centers

Criteria

Inclusion Criteria:

  • patient included in one of the registered cardiac stem cell therapy of the participating center

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01098591

Contacts
Contact: Mariann Gyongyosi, MD mariann.gyongyosi@meduniwien.ac.at

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Mariann Gyöngyösi, MD         mariann.gyongyosi@meduniwien.ac.at    
Contact: Mariann Gyöngyösi            
Sponsors and Collaborators
Medical University of Vienna
Hannover Medical School
IRT-Universite de Nantes France
Rikshospitalet University Hospital
Medical University of Silesia
Leiden University Medical Center
University of Novosibirsk Russia
Rigshospitalet, Denmark
University of Skopje
Asklepios Kliniken Hamburg GmbH
University of Debrecen
University Hospital of Targu Mures, Romania
Investigators
Principal Investigator: Mariann Gyongyosi, MD Medical University of Vienna
  More Information

No publications provided

Responsible Party: Mariann Gyongyosi, MD PhD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01098591     History of Changes
Other Study ID Numbers: MUW - Meta
Study First Received: March 30, 2010
Last Updated: June 10, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
meta-analysis
stem cell
cardiac
remodeling
MESS

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Coronary Disease
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013