INtramyocardial application of STEM cells in combination with transmyocardial laser revascularisation in coronary artery bypass graft patients

Heinrich-Heine-University (Germany)0 sites40 target enrollmentJune 15, 2007

Overview

No summary available.

Registry

who.int

Start Date

June 15, 2007

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

Heinrich-Heine-University (Germany)

•1\. 18 years (male or female gender)
•2\. Presence of at least two vessel coronary artery disease with at least one vessel that is not amenable to CABG, according to the angiogram, this vessel must serve an area of viable myocardium
•3\. Area of interest defined as part of free left ventricular wall with reduced contractility as shown either in ventriculographia during angiography and/or preoperative echo
•4\. Demonstration of reduced perfusion in the area of interest by cardiac Magnetic Resonance Imaging (MRI) or Computed Tomography (CT)
•5\. Global ejection fraction greater than 15% and less than 35%
•6\. Signed informed consent

•1\. Any condition that in the belief of the treating physician prevents successful stem cell collection or application (e.g. systemic infection, puncture for stem cell collection impossible)
•2\. Any condition that may adversely affect bone marrow (such as malignancy or prior irradiation to the pelvic bone)
•3\. Mitral valve insufficiency greater than II
•4\. History of ventricular arrhythmia, not controlled by medication and/or Automatic Implantable Cardioverter Defibrillator (AICD) required
•5\. Need of additional heart surgery (i.e. valve replacement)
•6\. Emergency or salvage operation defined as within 48 hours of diagnosis
•7\. Evidence of left ventricular thrombus
•8\. Previous heart surgery within the last six months (excluding implantation of pacemaker)
•9\. History of symptomatic carotid disease (e.g. any Transient Ischaemic Attack \[TIA], Prolonged Ischaemic Neurological Deficit \[PRIND], stroke) within the last three months prior to study intervention
•10\. Increased Creatine Kinase (CK) (greater than three times normal) in patients with unstable angina