Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2005-10-31
2007-05-31
Brief Summary
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Detailed Description
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The purpose of this study is to determine whether intracoronary transfer of autologous bone marrow cells can induce angiogenesis, subsequently improving regional myocardial perfusion, and finally resulting in improved systolic and diastolic left ventricular function in patients with severe ischemic heart failure.
35 patients with stable left ventricle function will - with four months interval - receive two treatments with bone marrow transplantation intracoronary in vessels supplying dysfunctional myocardial territories. Echocardiography is performed three times prior (four and two months and just before) and two times after (four and eight months after) therapy. It is a non-randomised trial, patients will enter as their own control.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Bone marrow transplantation
Eligibility Criteria
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Inclusion Criteria
2. Stable left ventricular ejection fraction \< 40%,
3. CCS class 2-3 and/or NYHA class 2-3, and
4. Signed informed consent.
Exclusion Criteria
2. Acute myocardial infarction within 3 months,
3. Atrial fibrillation, or
4. Severe comorbidity that could impact the patient's short-term survival (including primary hematologic disorders)
ALL
No
Sponsors
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Odense University Hospital
OTHER
Principal Investigators
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Per Thayssen, MDSci
Role: STUDY_DIRECTOR
Department of Cardiology, Odense University Hospital
Axel CP Diederichsen, phd
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, Odense University Hospital
Locations
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Department of Cardiology, Odense University Hospital
Odense, Odense C, Denmark
Countries
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References
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Diederichsen AC, Moller JE, Thayssen P, Videbaek L, Saekmose SG, Barington T, Kassem M. Changes in left ventricular filling patterns after repeated injection of autologous bone marrow cells in heart failure patients. Scand Cardiovasc J. 2010 Jun;44(3):139-45. doi: 10.3109/14017430903556294.
Other Identifiers
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Stem cell
Identifier Type: -
Identifier Source: org_study_id