ACTRN12611000219987
Withdrawn
Phase 2
A study of the effect of direct endomyocardial injection of autologous bone marrow cells on left ventricular ejection function in patients with end-stage ischaemic heart failure.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Heart failure
- Sponsor
- John Hunter Hospital
- Enrollment
- 20
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 \-80 years.
- •CCS classification II\-IV angina and/or NYHA classification II\-III heart failure symptoms.
- •Received stable and best” cardiac medical therapy including diuretics, long\-acting nitrates, beta\-blocker, and angiotensin\-converting enzyme inhibitors without control of symptoms.
- •Not suitable for conventional revascularization (due to diffuse disease, chronic total occlusion, lack of graftable vessels or any combination thereof).
- •LVEF \<40% by echocardiography.
- •Recent coronary angiogram (within the last 6 months) to document the coronary anatomy and insure the presence of Coronary Artery Disease (CAD) that is not amenable to standard revascularization procedures.
- •Serum creatinine less than 250mmol/L, normal liver function, and normal blood count: white blood cell (WBC) count, granulocytes; platelet count, haemolglobin (Hb).
- •Reversible perfusion defect on SPECT.
- •Hemodynamically stable.
- •Subject is willing to comply with specified follow\-up evaluations.
Exclusion Criteria
- •Atrial fibrillation.
- •History of syncope or major ventricular arrhythmias such as sustained ventricular tachycardia or ventricular fibrillation.
- •Severe valve disease.
- •Aortic or mitral valve prosthesis.
- •History of cancer in last 5 years.
- •Acute or chronic active sepsis, including human immunodeficiency virus (HIV) positive; hepatitis B or C positive.
- •Left ventricular (LV) wall thickness less than 8 mm in the target territory (by echocardiography or MRI).
- •LV thrombus and/or spontaneous echo\-contrast in the LV detected by echocardiography or LV aneurysm.
- •Severe aorto\-femoral\-iliac disease.
- •Recent heart attack within the last 30 days.
Outcomes
Primary Outcomes
Not specified
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Unknown
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