Intra-coronary transfusion of autologous CD34+ cells improves left ventricular function in patients with diffuse coronary artery disease (CAD) and non-candidates for coronary artery intervention
| ISRCTN | ISRCTN26002902 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26002902 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/08/2013
- Registration date
- 11/09/2013
- Last edited
- 17/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Despite state-of-the-art treatment, including medications, use of improved devices and techniques, and an increase in experience of coronary artery interventions, up to 20% of patients who have severely and diffusely atherosclerotic obstructive coronary artery disease (CAD) are not only unsuitable candidates for coronary artery intervention (i.e., either percutaneous coronary artery intervention [PCI] or coronary artery bypass grafting [CABG]) but also have an ineffective response to optimal medication. Therefore, finding a safe and effective alternative treatment for these patients is important. Stem cell therapy has been established as an attractive and promising treatment for improving various ischemia (decrease in blood supply) related organ dysfunctions, including the heart and vascular system. Additionally, some recent studies have demonstrated that intra-coronary transfusion (injection given directly into the heart) of CD34+ cells is safe and effective for improving ischemia-related left ventricular (LV) dysfunction. Surprisingly, no data has been reported regarding stem cell therapy for CAD patients in Taiwan. Besides, there has been no reported data to address the issue of whether intracoronary transfusion of CD34+ cells is an alternative treatment strategy for severely and diffusely atherosclerotic obstructive CAD patients worldwide. The aim of this study is to investigate the safety and effectiveness of intra-coronary delivery of CD34+ cells.
Who can participate?
Patients aged 20-80 years with severely and diffusely atherosclerotic obstructive CAD who are not candidates for PCI and CABG and with unsatisfactory results from other medical treatment.
What does the study involve?
The participants are randomly allocated to one of two groups. The study group receives intra-coronary transfusion of CD34+ cells into the diffusely atherosclerotic blood vessel. The control group receives optimal medical therapy.
What are the possible benefits and risks of participating?
The possible benefits are improvement of cardiac function and quality of life. The risks include arrhythmia, increased risk of angina or heart failure, stroke, claudication (pain in the legs due to reduced blood flow), hemorrhage, anemia, renal insufficiency (kidney failure) and electrolyte imbalance.
Where is the study run from?
Taiwan
When is the study starting and how long is it expected to run for?
The study started in January 2013 and it is expected to run for 3 years.
Who is funding the study?
National Science Council Taiwan, Republic of China.
Who is the main contact?
Dr Hon-Kan Yip
Contact information
Scientific
123, Ta Pei Road
Niao Sung District
Kaohsiung
83302
Taiwan
Study information
| Study design | Prospective randomized placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 randomized placebo controlled trial |
| Study objectives | It is reasonable to seek both the safety and feasibility and potential effects on parameters of improving left ventricular (LV) ischemia and function and clinical outcome of intracoronary infusion of CD34+ cells for patients who have angina pectoris due to severely and diffusely atherosclerotic obstructive CAD and are refractory to optimal medication who are not the candidates for both percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). |
| Ethics approval(s) | Chang Gung Memorial Hospital 101-4261C |
| Health condition(s) or problem(s) studied | Chronic ischemic heart disease |
| Intervention | Intervention: autologous endothelial progenitor cells (5x10^7) Control: optimal medical therapy |
| Intervention type | Other |
| Primary outcome measure | The safety of intracoronary 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. Clinical follow-up (1 week, 1 month, 3 months, 6 months, 9 months, 12 months). |
| Secondary outcome measures | 1. The efficacy of autologous intracoronary CD34+ cell therapy on improving degree of Angina Pectoris. 2. Quality of Life 3. LV function 4. Clinical Outcome in patients with severediffuse CAD Methods and time points: 1. Canadian Cardiovascular Society Angina Class and New York Heart Association functional class: 1 week, 1 month, 3 months, 6 months, 9 months, 12 months. 2. Electrocardiogram: per day during hospitalization, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months. 3. Echocardiography: 1 month, 3months, 6months. 4. Tl-201: 6 months. 5. Cardiac MRI: 6 months and 12 months. |
| Overall study start date | 01/01/2013 |
| Completion date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | Patients with age between 20-80 years-old who have angina pectoris resulted in severely and diffusely atherosclerotic obstructive CAD with refractory to optimal medication are not the candidates for both PCI or CABG |
| Key exclusion criteria | 1. Age less than 20 years or more than 80 years 2. Pregnant women 3. Patients with adventitious agents (like HIV, Hepatitis viruses) 4. Myocardial infarction (MI) within 3 months 5. Aortic stenosis or mitral stenosis 6. Congestive heart failure, New York Heart Association functional class (NYHA Fc.)IV 7. Malignancy or other severe disease with life span less than one year 8. Chronic kidney disease with CCr<20ml/min and end stage renal disease |
| Date of first enrolment | 01/01/2013 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
83302
Taiwan
Sponsor information
Government
No. 106
HoPing E. Road
Sec.2
Taipei
10622
Taiwan
| Website | http://web1.nsc.gov.tw/ |
|---|---|
"ROR" |
https://ror.org/02kv4zf79 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 | Yes | No | |
| Results article | results | 07/04/2020 | 15/04/2020 | Yes | No |
| Results article | results | 29/07/2020 | 17/12/2020 | Yes | No |
Editorial Notes
17/12/2020: Publication reference added.
15/04/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
21/12/2015: Publication reference added.
