Direct Endomyocardial Injection of Autologous Bone Marrow Cells to Treat Ischaemic Heart Failure (END-HF)

The University of Hong Kong (HKU)

Status and phase

Unknown

Phase 2

Conditions

Coronary Artery Disease

Treatments

Procedure: Endomyocardial Injection of Autologous Bone Marrow Cells

Procedure: Endomyocardial Injection of Plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT01150175

HKCTR-763

END-HF Version 1:17-5-08

Details and patient eligibility

About

The purpose of this study is to determine whether direct endomyocardial injection of autologous bone marrow cells is effective for enhancement of neovascularisation in patients with ischaemic heart failure.

Full description

Coronary artery disease (CAD) remains to be one of the leading causes of mortality and morbidity worldwide. Despite the optimal use of anti-anginal medications and coronary revascularization, a large number of patients with CAD suffer from severe symptoms with disabling angina and heart failure (HF). Experimental and pilot clinical studies provided evidence of the safety and potential efficacy of a strategy of intramyocardial transplantation of autologous bone marrow (BM) cells for neovascularisation of chronically ischemic myocardium. Nevertheless, the possible potent placebo effect on symptoms observed in these pilot studies highlights the need for a randomized, placebo-controlled group to prove the clinical efficacy of cell based angiogenic therapy for treatment of severe CAD.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18-80 years old
Canadian cardiovascular (CV) Class II-IV angina and/or NYHA class II-III HF symptoms
Received stable and "best" cardiac medical therapy including long-acting nitrates, beta-blocker, and angiotensin-converting enzyme inhibitors without control of symptoms.
Not suitable for conventional revascularization by their referring cardiologist.
LVEF <40% by echocardiography.
Recent coronary angiogram (within the last 6 months) to document the coronary anatomy and insure the presence of CAD that is not amenable to standard revascularization procedures.
creatinine less than 250mmol/L, normal liver function, and normal blood count: WBC, granulocytes; platelet count, Hb.
Reversible perfusion defect on single photon emission computed tomography (SPECT)
Able to walk on treadmill
Hemodynamically stable
Subject is willing to comply with specified follow-up evaluations.
All patients give written informed consent.

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 HIV positive; hepatitis B or C positive
Left ventricular wall thickness less than 8 mm in the target territory
Left ventricular 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