A study of the effect on heart function of direct myocardial injection of autologous bone marrow for treatment of patients with end-stage ischaemic heart failure.

Phase 2

Withdrawn

• Conditions: Heart failure; Coronary artery disease; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12611000219987
• Lead Sponsor: John Hunter Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn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

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.
Hypertrophic or restrictive cardiomyopathy.
Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.

Study & Design

• Study Type: Interventional
• Study Design: Not specified