Granulocyte-colony stimulating factor (G-CSF) mobilised autologous endothelial progenitor cells for refractory ischaemic heart disease

Phase 1

Completed

• Conditions: Patients with chronic ischaemic heart disease (IHD) on maximal medical therapy, who are not amenable to conventional revascularisation.; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12605000050651
• Lead Sponsor: The Victor Chang Cardiac Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-07-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the safety of G-CSF administration in 20 stable 'no-option' patients with refractory IHD.[]

Secondary Outcome Measures

Name	Time	Method
In this group of 20 'no-option' patients, to assess:<br>(I) the efficacy of G-CSF therapy (alone);[];(II) the efficacy of an intracoronary infusion of endothelial progenitor cells (as defined by the surface marker CD133);[];(III) the ex vivo properties of CD133+ cells.[]