Direct Endomyocardial Injection of Autologous Bone Marrow Cells to Treat Ischaemic Heart Failure
Direct Endomyocardial Injection of Autologous Bone Marrow Cells to Treat Ischaemic Heart Failure
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.
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.
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