Phase I / II Clinical Trial Regarding Vascular Regeneration Therapy by Transplantation of Autologous Peripheral Blood Endothelial Progenitor Cells (CD34+ Cells) in No-Option Patients With Chronic Myocardial Ischemia
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chest Pain
- Sponsor
- Foundation for Biomedical Research and Innovation
- Enrollment
- 1
- Locations
- 3
- Primary Endpoint
- Safety: Severe adverse events within 4 weeks after cell therapy
- Status
- Terminated
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Chronic severe CAD patients fulfilling all the following criteria are considered suitable for inclusion in the study.
- •At least 6 months since last episode of myocardial infarction or at least 3 months since initial anginal episode.
- •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
- •Reversible myocardial ischemia as revealed by sestamibi SPECT stress myocardial scintigraphy.
- •Patients for whom angioplasty and bypass are not indicated because of anatomical or procedural reasons or frequent reocclusion/restenosis following traditional revascularization.
- •Age is between 20 and 80 (at time of consent).
- •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).
- •Patients who can give informed consent themselves in writing.
Exclusion Criteria
- •Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.
- •Sustained ventricular tachycardia in a 24-hour ECG.
- •Chronic atrial fibrillation.
- •Less than 6 months since last episode of cerebral infarction.
- •Less than 6 months since last coronary angioplasty or less than 3 months since last bypass surgery.
- •Patients with unstable angina, with a treatment rating of 3 in the Braunwald system (refer to 5.4.), but a severity of III and a clinical rating of B or C.
- •Presence of left ventricular thrombus by echocardiography
- •Patients with a malignant tumor\*.
- •Patients with diabetic proliferating retinopathy\*\* (new Fukuda classification BI to BV).
- •Patients with chronic rheumatoid arthritis.
Outcomes
Primary Outcomes
Safety: Severe adverse events within 4 weeks after cell therapy
Efficacy: Severity of myocardial perfusion abnormality by sestamibi SPECT stress myocardial scintigraphy
Secondary Outcomes
- NYHA (New York Heart Association) classification
- Exercise tolerance by treadmill
- CCSAS (Canada Cardiovascular Society Anginal Score)
- Left ventricular function by cardiac MRI