Status:
UNKNOWN
Direct Endomyocardial Injection of Autologous Bone Marrow Cells to Treat Ischaemic Heart Failure
Lead Sponsor:
The University of Hong Kong
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 fa...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01150175
Start Date
July 1 2008
End Date
December 1 2011
Last Update
June 24 2010
Active Locations (1)
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1
Prof. HF Tse
Hong Kong, China