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

ISRCTN ISRCTN72853206
DOI https://doi.org/10.1186/ISRCTN72853206
Secondary identifying numbers N/A
Submission date
30/01/2012
Registration date
17/02/2012
Last edited
17/12/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Fan-Yen Lee
Scientific

123, Ta Pei Road
Niao Sung Hsiang
Kaohsiung
83301
Taiwan

Study information

Study designProspective randomized double-blind trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleIntra-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
Study objectivesIt 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(s)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
Health condition(s) or problem(s) studiedChronic ischemic heart disease
InterventionIntra-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 typeOther
Primary outcome measureThe 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 measures1. 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 study start date02/12/2011
Completion date01/12/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40
Total final enrolment38
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment02/12/2011
Date of final enrolment01/12/2014

Locations

Countries of recruitment

  • Taiwan

Study participating centre

123, Ta Pei Road
Kaohsiung
83301
Taiwan

Sponsor information

National Science Council (Taiwan)
Government

No.106, HoPing East Road
Sec. 2
Taipei
10622
Taiwan

Website http://web1.nsc.gov.tw/
ROR logo "ROR" https://ror.org/02kv4zf79

Funders

Funder type

Government

National Science Council (Taiwan) ref: 100-2314-B-182A-077
Government organisation / National government
Alternative name(s)
National Science Council, Taiwan, National Science Council of Taiwan, NSC
Location
Taiwan

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2015 17/12/2020 Yes No
Results article results 29/07/2020 17/12/2020 Yes No

Editorial Notes

17/12/2020: Publication reference and total final enrolment added.
14/06/2017: Plain English summary added.