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Alster Stem Cells - Intramyocardial Stem Therapy

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ClinicalTrials.gov Identifier: NCT00939042
Recruitment Status : Unknown
Verified April 2011 by Asklepios proresearch.
Recruitment status was:  Active, not recruiting
First Posted : July 14, 2009
Last Update Posted : April 15, 2011
Sponsor:
Information provided by:
Asklepios proresearch

Brief Summary:
Study to assess the efficacy of intramyocardial bone marrow derived mononuclear cell therapy concerning left ventricular ejection fraction as measured by echocardiography.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : January 2009
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]


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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

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

Responsible Party: Cornelia Wolf, ASKLEPIOS proresearch
ClinicalTrials.gov Identifier: NCT00939042     History of Changes
Other Study ID Numbers: 1777
2008-004625-42
First Posted: July 14, 2009    Key Record Dates
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