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

NCT ID: NCT01150175

Last Updated: 2010-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-12-31

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 failure.

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 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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Autologous bone marrow cells

Group Type: EXPERIMENTAL

Endomyocardial Injection of Autologous Bone Marrow Cells

Intervention Type: PROCEDURE

Endomyocardial Injection of Autologous Bone Marrow Cells

Plasma

Group Type: PLACEBO_COMPARATOR

Endomyocardial Injection of Plasma

Intervention Type: PROCEDURE

Endomyocardial Injection of Plasma

Interventions

Endomyocardial Injection of Autologous Bone Marrow Cells

Endomyocardial Injection of Autologous Bone Marrow Cells

Intervention Type: PROCEDURE

Endomyocardial Injection of Plasma

Endomyocardial Injection of Plasma

Intervention Type: PROCEDURE

Other Intervention Names

END-HF; END-HF

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

The University of Hong Kong

Locations

Prof. HF Tse

Hong Kong, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Teguh Santoso, PhD

Role: primary

tsantoso@cbn.net.id

31930371

Thambar Sukumaran, PhD

Role: backup

Other Identifiers

END-HF Version 1:17-5-08

Identifier Type: -

Identifier Source: secondary_id

HKCTR-763

Identifier Type: -

Identifier Source: org_study_id