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

Coronary Artery Disease Clinical Trial

— END-HF  

Official title:

Double-blind Placebo Controlled Trial on Direct Endomyocardial Injection of Autologous Bone Marrow Cells for Enhancement of Neovascularization in Patients With Ischaemic Heart Failure (END-HF)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01150175
• Other study ID #: HKCTR-763
• Secondary ID: END-HF Version 1
• Status: Recruiting
• Phase: Phase 2
• First received: May 24, 2010
• Last updated: June 23, 2010
• Start date: July 2008
• Est. completion date: December 2011

Study information

• Verified date: June 2010
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Endomyocardial Injection of Autologous Bone Marrow Cells
Endomyocardial Injection of Autologous Bone Marrow Cells
• Endomyocardial Injection of Plasma
Endomyocardial Injection of Plasma

Locations

Country	Name	City	State
China	Prof. HF Tse	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI ejection fraction		MRI ejection fraction changed from baseline to 6 months	Yes
Secondary	Changes in exercise duration and MVO2 using standardized treadmill testing(modified Bruce protocol) from baseline to 6 months		Baseline to 6 months	Yes