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Alster Stem Cells - Intramyocardial Stem Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Asklepios proresearch.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Asklepios proresearch
ClinicalTrials.gov Identifier:
NCT00939042
First received: July 13, 2009
Last updated: April 14, 2011
Last verified: April 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Cornelia Wolf, ASKLEPIOS proresearch
ClinicalTrials.gov Identifier: NCT00939042     History of Changes
Other Study ID Numbers: 1777, 2008-004625-42
Study First Received: July 13, 2009
Last Updated: April 14, 2011
Health Authority: Germany: Ministry for Social and Family Affairs, Health and Consumer Protection

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

ClinicalTrials.gov processed this record on November 25, 2014