CompletedPhase 2ACTRN12605000050651

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

Sponsor

The Victor Chang Cardiac Research Institute

Enrollment

20 participants

Start Date

Jan 19, 2004

Study Type

Interventional

Conditions

Patients with chronic ischaemic heart disease (IHD) on maximal medical therapy, who are not amenable to conventional revascularisation.

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.

Eligibility

Sex: Both males and femalesMin Age: 21 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether collecting and reinfusing a patient's own stem cells (mobilized with G-CSF) can help treat severe heart disease that cannot be treated with surgery or stenting. It is for adults aged 21 and older with severe chronic angina (chest pain) who have exhausted other treatment options. Participation involves injections to mobilize stem cells and follow-up heart monitoring.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 intracoronary infusion of either CD133+ or unselected cells is performed. Final CA is 3 months thereafter.

Locations(1)

Australia

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ACTRN12605000050651