Back to resultsAlster Stem Cells - Intramyocardial Stem Therapy
Primary Purpose
Acute Myocardial Infarction, Early Left Ventricular Dysfunction
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention
BMNC therapy
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction
Eligibility 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
Sites / Locations
- Asklepios Klinik St. Georg
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
PCI plus BNNC Therapy after acute myocardial infarction
Percutaneous Coronary Intervention after acute myocardial infarction
Outcomes
Primary Outcome Measures
Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF).
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.
Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00939042
Brief Title
Alster Stem Cells - Intramyocardial Stem Therapy
Official Title
Percutaneous Intramyocardial Cell Therapy After Acute Myocardial Infarction Using Bone Marrow Mononuclear Cells
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
PI left institution
Study Start Date
January 2009 (Actual)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asklepios proresearch
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study to assess the efficacy of intramyocardial bone marrow derived mononuclear cell therapy concerning left ventricular ejection fraction as measured by echocardiography.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Early Left Ventricular Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
PCI plus BNNC Therapy after acute myocardial infarction
Arm Title
2
Arm Type
Active Comparator
Arm Description
Percutaneous Coronary Intervention after acute myocardial infarction
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention
Intervention Description
common Percutaneous Coronary Intervention
Intervention Type
Procedure
Intervention Name(s)
BMNC therapy
Intervention Description
Injection of BMNC after common PCI
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl-Heinz Kuck, MD, PhD
Organizational Affiliation
Asklepios Klinik St. Georg, Department of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Alster Stem Cells - Intramyocardial Stem Therapy
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