Plain English Summary
Background and study aims
Coronary artery disease occurs when the heart's blood supply is blocked or interrupted by a build-up of fatty substances in the coronary arteries. Up to 20% of patients with severe coronary artery disease are unsuitable candidates for surgical treatment and also do not respond to medication. It is therefore important to finding a safe and effective alternative treatment for these patients. Stem cell therapy is the use of stem cells to treat or prevent a disease or condition. Recent studies have demonstrated that transfusion of CD34+ stem cells into the heart is safe and effective for improving heart dysfunction. The aim of this study is to test the safety, effectiveness and best dose of CD34+ cells in patients with severe coronary artery disease.
Who can participate?
Patients aged 20-80 with severe coronary artery disease who are not candidates for surgical treatment and do not respond to medication
What does the study involve?
All participants receive eight doses of G-CSF for 4 days, which makes some stem cells move from the bone marrow into the blood. The participants’ CD34+ cells are collected using a machine through a tube inserted into a vein in the groin (femoral catheter) for 3-4 hours. After measuring the number of CD34+ cells, the CD34+ cells are delivered into the heart on the same day. The participants are randomly allocated to receive one of two doses of CD34+ cells through a tube into the heart (cardiac catheterization). Both groups also receive medical treatment as usual. The effectiveness and best dose are assessed and participants are monitored for any severe side effects during hospitalization and follow-up in the 1st week, 1st month, and every 3 months for one year after treatment.
What are the possible benefits and risks of participating?
The results of this study will provide important information about the effectiveness of stem cells for treating heart disease. Patients receive regular clinical follow-up one year and may benefit from early detection of heart failure. The possible risks include the risk during G-CSF injection (mainly bone soreness), during femoral catheter insertion (mainly hematoma [an abnormal collection of blood outside of a blood vessel]), during CD34+ cell collection (mainly muscle cramp due to low blood calcium), and during cardiac catheterization (death, heart rhythm problems, tear, blockage, infection and hematoma).
Where is the study run from?
Kaohsiung Chang Gung Memorial Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
December 2011 to December 2014
Who is funding the study?
National Science Council (Taiwan)
Who is the main contact?
Dr Fan-Yen Lee
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Intra-coronary transfusion of autologous CD34+ cells improves left ventricular function in patients with diffuse coronary artery disease and non candidates for coronary artery intervention: a randomised controlled trial
Acronym
Study hypothesis
It is reasonable to seek both the safety, feasibility and potential effects on parameters of improving left ventricular (LV) ischemia and function and clinical outcome of intra-coronary infusion of CD34+ cells for patients who have angina pectoris that resulted in severely and diffusely atherosclerotic-obstructive coronary artery disease (CAD) with refractory to optimal medication are not the candidates for both Percutaneous Coronary Intervention (PCI) or coronary artery bypass graft (CABG), especially in the age of donor shortage.
Ethics approval
1. Institutional Review Committee on Human Research, Kaohsiung Chang Gung Memorial Hospital, 31/03/2011, ref: 99-3985A
2. Department of Health, Taiwan, 02/12/2011, ref: 1005056011
Study design
Prospective randomized double-blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Chronic ischemic heart disease
Intervention
Intra-coronary delivery of autologous CD34+ cells are performed in our cardiac catheterization laboratory at day 5 during hospitalization. While one group will receive 1x107 CD34+ cells , the other group will receive 3x107 CD34+ cells. Both groups will receive medical treatment as usual. Follow-up duration is one year.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The safety of intra-coronary delivery of autologous CD34+ cells in patients with severely and diffusely atherosclerotic obstructive CAD who are not candidates for PCI and CABG and unsatisfactory medical treated result
Patients will be monitored for any severe adverse events (mortality, malignant arrhythmia, stroke, myocardial infarction and re-admission for congestive heart failure) during hospitalization and follow-up at OPD in the 1st week, 1st month, and per 3 months for one year after therapy.
Secondary outcome measures
1. The efficacy and optimal dose of autologous intra-coronary CD34+ cell therapy on improving degree of angina pectoris
2. Quality of Life - Short Form (SF-36)
3. LV Function
4. Clinical outcome in patients with severe-diffuse CAD
5. Degree of angina pectoris with Canadian Cardiovascular Society class II- IV angina
Measured at week one, 1, 3, 6, 9 and 12 months
Overall trial start date
02/12/2011
Overall trial end date
01/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients aged 20-80
2. Have angina pectoris resulted in severely and diffusely atherosclerotic-obstructive CAD with refractory to optimal medication not the candidates for both PCI or CABG
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Age <20 years or > 80 years
2. Pregnant women
3. Patients with adventitious agents [like:Human immunodeficiency virus (HIV), Hepatitis viruses]
4. Recent myocardial infarction (MI) within 3 months
5. Aortic stenosis or mitral stenosis
6. Congestive heart failure
7. New York Heart Association Functional Class IV (NYHA Fc.IV)
8. Malignancy or other severe disease with life span less than one year
9. Chronic kidney disease with creatinine clearance (CCr) <20ml/min and end stage renal disease
Recruitment start date
02/12/2011
Recruitment end date
01/12/2014
Locations
Countries of recruitment
Taiwan
Trial participating centre
123, Ta Pei Road
Kaohsiung
83301
Taiwan
Sponsor information
Organisation
National Science Council (Taiwan)
Sponsor details
No.106
HoPing East Road
Sec. 2
Taipei
10622
Taiwan
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Science Council (Taiwan) ref: 100-2314-B-182A-077
Alternative name(s)
National Science Council, Taiwan, National Science Council of Taiwan, NSC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Taiwan
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list