None listed
Conditions
Brief summary
Approval granted to commence the trial in late 2003. The trial is conducted with the oversight of an independant data and safety monitoring board.
Interventions
After baseline cardiac assessment (CA) [Seattle Angina Questionnaire (SAQ), Bruce exercise stress test (EST), persantin-Sestamibi and dobutamine-echocardiographic imaging], stable 'no option' IHD patients receive open-label G-CSF 10microg/kg for 5 days, with an EST (to facilitate myocardial cytokine generation and stem cell trafficking) on the 4th and 6th days. After 3 months, CA and the same regimen of G-CSF and ESTs is repeated, but in addition, leucopheresis and a randomized double-blinded in
After baseline cardiac assessment (CA) [Seattle Angina Questionnaire (SAQ), Bruce exercise stress test (EST), persantin-Sestamibi and dobutamine-echocardiographic imaging], stable 'no option' IHD patients receive open-label G-CSF 10microg/kg for 5 days, with an EST (to facilitate myocardial cytokine generation and stem cell trafficking) on the 4th and 6th days. After 3 months, CA and the same regimen of G-CSF and ESTs is repeated, but in addition, leucopheresis and a randomized double-blinded intracoronary infusion of either CD133+ or unselected cells is performed. Final CA is 3 months thereafter.
Sponsors
The Victor Chang Cardiac Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Angiographically documented coronary artery disease, not amenable to other forms of revascularisation. 2. Patients with chronic angina who have been classified according to the Canadian Cardiovascular Society Grading Scale for angina as class III or IV. 3. Age >21 years and must be mentally competent. 4. Subjects will be at maximum tolerable medical therapy for angina pectoris and will not be candidates for other therapy, such as bypass graft surgery or percutaneous interventional therapy.
Exclusion criteria
1. Patients with uncontrolled heart failure.2. Patients with a left ventricular ejection fraction of <20% (by nuclear scanning, echocardiography or angiography).3. Patients who have had a myocardial infarction within 3 months.4. Patients with unstable angina.5. Patients with a history of serious ventricular arrhythmias who are currently taking medications for that indication or who have an automatic implantable cardiac defibrillator (AICD).6. Presence of diabetic retinopathy. This will be excluded on the basis of a formal evaluation of all diabetic patients by a specialist ophthalmologist, including fluorescein angiography, to exclude active (within the last 3 month) proliferative diabetic retinopathy.7. Current or prior history of neoplasia.8. Vulnerable populations including minors, prisoners, persons who are institutionalised or who are unable to give informed consent.9. Patients with other medical or psychiatric problems, which in the opinion of the investigator preclude them from participating in the study.10. Patients unwilling to return for follow up visits.11. Patients participating in another experimental protocol.12. Patients who are pregnant or breast-feeding.13. Claustrophobia or orthopaedic difficulties that would impede nuclear scanning.14. Patients must be deemed haemodynamically stable:-Minimum systolic blood pressure of 90mm Hg -Urine output less than 0.5cc/kg/hr for a period of eighteen hours or greater would exclude patient from study -Patients cannot be using inotropic agents such as dopamine, dobutamine, levophed, adrenaline, noradrenaline, amrinone, or milrinone.15. Patients must not have signs, symptoms or biochemical evidence of multi-organ failure.16. Patients must not have a significant active infection which is uncontrolled by antibiotic, antiviral or antifungal therapy at entry into the study, or at the time of subsequent leukopharesis procedures.17. Minimum hemoglobin of 8.0g/dl, white blood cell of 2,000/mm3 and platelet count of 100,000/mm3.18. Patients who are either candidates for, or who have received a Left Ventricular Assist Device.19. Patients who have received a heart or other organ transplant.20. Patients taking any form of immunosuppressant medication (including systemic steroids), for whatever reason.21. Patients who are candidates for heart transplantation. Such patients must not be either on the active transplant waiting list, or be under consideration for enrolment on the waiting list.22. Intolerance or allergy to HMG Co-A reductase inhibitors.
Outcome results
None listed