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

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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
11. End Stage Renal Disease (ESRD) defined as serum creatinine level greater than 3.5 mg/dL, or dialysis (renal replacement therapy)
12. Concurrent active chemotherapy for cancer
13. Life expectancy less than two years
14. Platelet count less than 100000/µl
15. Pregnancy
16. Participation in other clinical trials in the last 30 days
17. Active hepatitis-infection
18. Human Immunodeficiency Virus (HIV)-infection
19. Anaemia
20. Haemorrhagic diathesis in medical history
21. Sensitivity and incompatibility against used drugs or excipients
22. Disseminated intravascular coagulation in medical history
23. Clinically active infection at the time of operation
24. Patient not able to attend follow-up as specified in the protocol
25. No informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: occurrence of Major Adverse Cardiac Event (MACE) assessed at three months after surgical study treatment. MACE will be assessed by the investigator for relationship to the interventions under the investigation in this trial.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints (assessed at 3, 6 and 12 months follow-up):<br>1. MACE assessed at 6 and 12 months follow-up<br>2. Cardiac Adverse Events (AEs) defined in the Common Toxicity Criteria (CTC) (assessed form onset of surgery up to 12 months follow-up)<br>3. Severity of angina and extent of treatment in comparison to baseline (Canadian Cardiovascular Society [CCS] classification) (assessed at 3, 6 and 12 months follow-up)<br>4. Quality of Life in comparison to baseline (increase of exercise tolerance in Seattle Angina Questionnaire) (assessed at 3, 6 and 12 months follow-up)<br>5. Baseline Regional cardiac function by cardiac MRI is assessed and in comparison to cardiac MRI at six months follow-up (in case of an contraindication against cardiac MRI the cardiac function is assessed by cardiac CT)