A Phase III randomized, double-blinded, placebo-controlled trial to investigate the impact of intra-coronary transfusion of G-CSF mobilized autologous circulating hematopoietic stem/progenitor cells (CPC) therapy in patients with diffuse coronary artery disease who are not candidates for coronary artery interventio

Phase 3

• Conditions: Diffuse Coronary Artery Disease (CAD) and non candidates for coronary artery intervention; Circulatory System

• Registration Number: ISRCTN14054375
• Lead Sponsor: Chang Gung Memorial Hospital, Chang Gung Medical Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-26
• Last Update Posted: 22 January 2024
• Study Completion: 2026-08-20

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Age between 20-80 y/o, coronary syndrome, subjects with severe diffuse coronary artery disease who have been diagnosed by cardiac catheterization, not suitable for cardiac catheterization or surgical coronary artery bypass surgery after cardiac internist and surgeons evaluate, and receiving optimal medical therapy, including antiplatelet therapy (aspirin or clopidogrel), ACEI/ARB, beta-blocker, calcium channel blocker, nitrates, etc. The symptom of chest pain is still evaluated as Canadian Cardiovascular Society class II-IV Angina. LVEF =55 % examined by 3D echo (i.e. LVEF =60 % indicates normal. After stem cell treatment, the LVEF is improved up to 5 %, unchanged or continually deteriorated. Therefore, the criteria of enrollment of LVEF is =55 %). Patients are willing to accept the G-CSF mobilized autologous circulating hematopoietic stem/progenitor cells (CPC) treatment through cardiac catheterization, and are willing to join this study follow-up.
The severe diffuse coronary artery disease is defined as follows:
1. Clinical symptoms of angina (Canadian Cardiovascular Society class II-IV)
2. Tl-201 scan presents reversible ischemic changes (results should be adopted within 6 months)
3. Highly diffuse vascular lesions show in angiography results (continuous normal segmental vessels length no longer than 10 mm), and the degree of stenosis more than 75% (results can be adopted within 6 months)
4. Due to vascular occlusion showed diffuse and too small, not to be suitable for PCI (angioplasty nowhere to be implemented) or CABG (which can be accessed at no normal blood vessels) analyzed by PCI and CABG experts. The vessel must be severe diffuse stenosis (unsuitable for CABG)

Exclusion Criteria

1. Age <20 y/o or >80 y/o
2. Pregnant or breastfeeding women
3. No adventitious agents, ex. HIV infection, HBV and HCV carriers (HBsAg+ or anti-HCV +) (subjects without examination of HIV, HBV and HCV are excluded)
4. Myocardial infarction within 3 months, stent placement within 3 months
5. Severe aortic or mitral stenosis
6. Asthma and not suitable for cardiac catheterization treatment (including NYHA functional class IV)
7. Malignant or hematologic disease. Severe disease with life span less than one year
8. Chronic kidney disease (CCr <20 ml/min) and patients receiving dialysis
9. Under immunosuppressive medications
10. Autoimmune diseases
11. Contraindication to G-CSF
12. The subject previously received cell therapy
13. Participating in another clinical study and planning to participate in another clinical study during the course of this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eft ventricular ejection fraction (LVEF) examined by 3D echo and cardiac MRI at baseline (D6) and 12 months