Status:
COMPLETED
Bypass Surgery and CD133 Marrow Cell Injection for Treatment of Ischemic Heart Failure
Lead Sponsor:
German Heart Institute
Collaborating Sponsors:
Miltenyi Biomedicine GmbH
Conditions:
Coronary Artery Disease With Need for Bypass Surgery
Myocardial Ischemia, Angina Pectoris
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Cell transplantation for treatment of heart failure is a novel field of translational research that offers the perspective of developing curative approaches by regenerating or "rejuvenating" lost and/...
Detailed Description
Beginning in 2001, a phase-1 equivalent feasibility and safety evaluation of intramyocardial injection of autologous CD133+ bone marrow cells during elective CABG surgery was conducted at Rostock Univ...
Eligibility Criteria
Inclusion
- Coronary artery disease with indication for CABG surgery
- Reduced global left ventricular ejection fraction by transthoracic echocardiography at rest (EF ≤ 35%)
- Presence of a localized akinetic/hypokinetic/hypoperfused area of LV myocardium for defining the target area
- Informed consent of the patient
- Age \> 18 years
Exclusion
- Emergency operation
- Presence of aortic valve disease requiring concomitant valve replacement
- Debilitating other disease: Degenerative neurologic disorders, psychiatric disease, terminal renal failure requiring dialysis, previous organ transplantation, active malignant neoplasia
- History of ventricular arrhythmia (≥ Lown III)
- Impaired ability to comprehend the study information
- Absent informed written consent
- Apparent infection (CRP ≥ 20 mg/L, fever (≥38.5° C)
- Acute myocardial infarction
- contraindication for MRI assessment
- Pregnancy or lactation
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00462774
Start Date
April 1 2007
End Date
June 1 2011
Last Update
January 16 2013
Active Locations (1)
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1
Deutsches Herzzentrum Berlin
Berlin, Germany, 13353