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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Endomyocardial Injection of Autologous Bone Marrow Cells
Endomyocardial Injection of Plasma
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring END-HF

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prof. HF TseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Autologous bone marrow cells

Plasma

Arm Description

Outcomes

Primary Outcome Measures

MRI ejection fraction

Secondary Outcome Measures

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

Full Information

First Posted
May 24, 2010
Last Updated
June 23, 2010
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01150175
Brief Title
Direct Endomyocardial Injection of Autologous Bone Marrow Cells to Treat Ischaemic Heart Failure
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
END-HF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous bone marrow cells
Arm Type
Experimental
Arm Title
Plasma
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Endomyocardial Injection of Autologous Bone Marrow Cells
Other Intervention Name(s)
END-HF
Intervention Description
Endomyocardial Injection of Autologous Bone Marrow Cells
Intervention Type
Procedure
Intervention Name(s)
Endomyocardial Injection of Plasma
Other Intervention Name(s)
END-HF
Intervention Description
Endomyocardial Injection of Plasma
Primary Outcome Measure Information:
Title
MRI ejection fraction
Time Frame
MRI ejection fraction changed from baseline to 6 months
Secondary Outcome Measure Information:
Title
Changes in exercise duration and MVO2 using standardized treadmill testing(modified Bruce protocol) from baseline to 6 months
Time Frame
Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Prof. HF Tse
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teguh Santoso, PhD
Phone
31930371
Email
tsantoso@cbn.net.id
First Name & Middle Initial & Last Name & Degree
Thambar Sukumaran, PhD
First Name & Middle Initial & Last Name & Degree
David Siu, MBBS

12. IPD Sharing Statement

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

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