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Alster Stem Cells - Intramyocardial Stem Therapy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by Asklepios proresearch.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00939042
First Posted: July 14, 2009
Last Update Posted: April 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Asklepios proresearch
  Purpose
Study to assess the efficacy of intramyocardial bone marrow derived mononuclear cell therapy concerning left ventricular ejection fraction as measured by echocardiography.

Condition Intervention Phase
Acute Myocardial Infarction Early Left Ventricular Dysfunction Procedure: Percutaneous Coronary Intervention Procedure: BMNC therapy Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Intramyocardial Cell Therapy After Acute Myocardial Infarction Using Bone Marrow Mononuclear Cells

Resource links provided by NLM:


Further study details as provided by Asklepios proresearch:

Primary Outcome Measures:
  • Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF). [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Comparison of th eexplanatory power of echocardiography, endocardial left ventricular electromechanical mapping (LVEMM) with NOGA and cardiac MRI as an endpoint for myocardial regeneration. [ Time Frame: 12 months ]
  • Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters. [ Time Frame: 12 months ]

Estimated Enrollment: 40
Study Start Date: January 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
PCI plus BNNC Therapy after acute myocardial infarction
Procedure: BMNC therapy
Injection of BMNC after common PCI
Active Comparator: 2
Percutaneous Coronary Intervention after acute myocardial infarction
Procedure: Percutaneous Coronary Intervention
common Percutaneous Coronary Intervention

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LVDF < 45% after timely (max. 6 hours after the onset of symptomps) successful PCI
  • conventional therapy according to the ESC guidelines for heart failure
  • BMI > 20 and < 35

Exclusion Criteria:

  • PCI elder then 21 days
  • relevant valvular disease
  • history of stroke/multivessel disease/thromboembolic event etc.
  • DM Type I
  • pregancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939042


Locations
Germany
Asklepios Klinik St. Georg
Hamburg, Germany
Sponsors and Collaborators
Asklepios proresearch
Investigators
Principal Investigator: Karl-Heinz Kuck, Prof. Dr. med. Asklepios Klinik St. Georg, Department of Cardiology
  More Information

Responsible Party: Cornelia Wolf, ASKLEPIOS proresearch
ClinicalTrials.gov Identifier: NCT00939042     History of Changes
Other Study ID Numbers: 1777
2008-004625-42
First Submitted: July 13, 2009
First Posted: July 14, 2009
Last Update Posted: April 15, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ventricular Dysfunction
Ventricular Dysfunction, Left
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases