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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Endomyocardial Injection of Autologous Bone Marrow Cells; Procedure: Endomyocardial Injection of Plasma

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Recruiting
    • Prof. HF Tse
    • Contact: Teguh Santoso, PhD; Phone Number: 31930371; Email: tsantoso@cbn.net.id
    • Contact: Thambar Sukumaran, PhD
    • Sub-Investigator: David Siu, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autologous bone marrow cells	Procedure: Endomyocardial Injection of Autologous Bone Marrow Cells; Endomyocardial Injection of Autologous Bone Marrow Cells; Other Names: END-HF
Placebo Comparator: Plasma	Procedure: Endomyocardial Injection of Plasma; Endomyocardial Injection of Plasma; Other Names: END-HF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MRI ejection fraction	MRI ejection fraction changed from baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in exercise duration and MVO2 using standardized treadmill testing(modified Bruce protocol) from baseline to 6 months	Baseline to 6 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Anticipated): June 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: May 24, 2010
• First Submitted That Met QC Criteria: June 23, 2010
• First Posted (Estimate): June 24, 2010

Study Record Updates

• Last Update Posted (Estimate): June 24, 2010
• Last Update Submitted That Met QC Criteria: June 23, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: END-HF
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Failure; Coronary Artery Disease
• Other Study ID Numbers: HKCTR-763; END-HF Version 1:17-5-08