Angina, Chest Pain, Chronic Myocardial Ischemia, Coronary Artery Disease, Myocardial Infarction
Conditions
Keywords
Angina, Heart diseases, Pain, Vascular diseases
Brief summary
The purpose of this study is to determine if stem cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will relieve your chest pain, increase the blood flow, and/or improve the cardiac contractility (function) by regenerating blood vessels in your heart.
Detailed description
Chronic myocardial ischemia (MI) is a progressive disease, which arises as a result of atherosclerosis in coronary arteries. Prognosis of chronic MI is poor, and no effective treatments have been established in patients who are not eligible for the traditional revascularization therapies such as angioplasty and bypass procedures due to the inappropriate anatomy of the coronary arteries or frequent reocclusion following revascularization. Therefore, it is necessary to establish novel revascularization treatment to improve prognosis of the no-option patients. We will study the safety and clinical efficiency of vascular regeneration by means of transplantation of autologous peripheral blood endothelial progenitor cells (CD34 positive cells) in patients with severe chronic coronary artery disease (CAD) who are not eligible for traditional revascularization treatments. The primary endpoint is the severity of myocardial ischemia identified by sestamibi SPECT stress myocardial scintigraphy and the evaluation of adverse effect rates, while the secondary endpoints are evaluation of CCSAS and NYHA classification, regional myocardial blood flow as revealed by PET scan, and various left ventricular function indices.
Interventions
Sponsors
Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan
Kobe City General Hospital
Okayama University School of Medicine
Foundation for Biomedical Research and Innovation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
-Chronic severe CAD patients fulfilling all the following criteria are considered suitable for inclusion in the study. 1. At least 6 months since last episode of myocardial infarction or at least 3 months since initial anginal episode. 2. Patients fulfilling either of the following criteria based on the extent of CAD by coronary angiography and LVEF by echocardiography. * Patients with single vessel CAD and LVEF \< 50% * Patients with multivessel CAD 3. Reversible myocardial ischemia as revealed by sestamibi SPECT stress myocardial scintigraphy. 4. Patients for whom angioplasty and bypass are not indicated because of anatomical or procedural reasons or frequent reocclusion/restenosis following traditional revascularization. 5. Age is between 20 and 80 (at time of consent). 6. Exercise tolerance time (ETT) duration ≥ 3 minutes and \< 13 minutes on a modified Bruce protocol on 2 consecutive tests (\> 24 hours but \< 2 weeks apart), with the difference between the 2 exercise times within 25% of their mean (Patients should not be informed of exercise restrictions required for entry into the study). 7. Patients who can give informed consent themselves in writing.
Exclusion criteria
* Any one of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Severity of myocardial perfusion abnormality by sestamibi SPECT stress myocardial scintigraphy | — |
| Safety: Severe adverse events within 4 weeks after cell therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| CCSAS (Canada Cardiovascular Society Anginal Score) | — |
| NYHA (New York Heart Association) classification | — |
| Exercise tolerance by treadmill | — |
| Left ventricular function by cardiac MRI | — |
Countries
Japan
Outcome results
None listed