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Adult stem cells and G-CSF in chronic ischaemic heart disease

Granulocyte colony stimulating factor (G-CSF) in Angina patients with Ischaemic heart disease to stimulate Neovascularisation.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000354482
Acronym
GAIN II
Enrollment
20
Registered
2007-07-03
Start date
2007-06-18
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Angina is a medical term used to describe pain (usually felt in the chest) due to coronary artery disease causing reduced blood flow to the heart. We are investigating the use of G-CSF to treat chronic angina in patients who have failed standard treatment with medications and or coronary stenting/coronary artery bypass surgery. G-CSF is a man made version of a naturally occuring hormone. There is experimental evidence that G-CSF can stimulate the formation of new blood vessels in the heart and protect heart muscle cells. Through these effects, we hypothesise that patients will derive improvements in blood flow to the heart and hence angina symptoms. We will be measuring the effects of G-CSF on blood flow to the heart with cardiac magnetic resonance imaging (MRI scan).

Interventions

Granulocyte colony stimulating factor Subcutaneous Commenced at 4.5 mcg/kg/d Three 5 day cycles (each cycle fortnight apart)

Sponsors

St Vincent's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Canadian class III/IV angina2. Angiographically proven coronary artery disease3. Demonstrable reversible ischaemia on adenosine stress cardiac MRI.

Exclusion criteria

1. MI < 3 months2. Unstable angina3. Uncontrolled heart failure. 4. EF < 20%5. Significant (>50%) left main or left main equivalent disease6. Advanced coronary artery bypass graft disease.7. Factors preventing MRI including permanent pacemaker, implantable defibrillator, neurostimulator, severe claustrophobia8. Contraindications to adenosine including high degree heart block, severe bronchospasm.9. Proliferative retinopathy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026