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Alster Stem Cells - Intramyocardial Stem Therapy

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. Identifier: NCT00939042
Recruitment Status : Terminated (PI left institution)
First Posted : July 14, 2009
Last Update Posted : April 6, 2018
Information provided by (Responsible Party):
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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Study Start Date : January 2009
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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 ]

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT00939042

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

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Responsible Party: Asklepios proresearch Identifier: NCT00939042     History of Changes
Other Study ID Numbers: 1777
First Posted: July 14, 2009    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2011

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