Combination autologous peripheral blood-derived stem cell/progenitor cell (CD34+) + stem cells and hyperbaric oxygen therapy for the treatment of severe limb ischemia: investigate the safety and efficacy

Ministry of Science and Technology (Taiwan)0 个研究点目标入组 40 人开始时间: 2017年10月3日最近更新: 2023年6月5日

试验速览

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•Age between 20-80 with severe limb ischemia due to diffuse atherosclerosis. Inclusion criteria for the study were all of the following:
•1. Ischemic peripheral vascular disease with rest pain defined as pain that occurs at
•night and at rest. Clinical evaluation by Fontaine classification (Fontaine stage III: rest pain, stage IV: ulcer and/or necrosis)
•2. Ankle–brachial index (ABI)<0.7
•3. A non-surgical candidate for revascularization, for example, diffuse multi-segment disease, inability to locate a suitable vein for grafting, or extensive infra-popliteal disease not amenable to a vascular graft
•4. The image analysis includes the MRA or angiocardiography by diagnostic intravascular catheter (depended on clinical results). The above results show that obstruction more than 75% stenosis will considerate into this test
•5. Use of contraception
•6. The trialists accept the laboratory data within 3 months since initial screening
•7. TcPO2<45mmHg

•1. Age <20 y/o or >80 y/o
•2. Pregnant or feeding women
•3. Adventitious agents (HIV, syphilis, hepatitis B virus, hepatitis C virus, will be excluded. If the examination result is positive, Centers of Disease Control will be notified by law)
•4. Infective disease
•5. Myocardial infarction within 3 months, heart failure, or functional class IV
•6. Malignant or hematologic disease, or severe disease with life span less than one year
•7. End stage renal disease or eGFR less than 30 ml/min
•8. Patients after treatment improved in the case using bypass surgery or stenting ischemic cardiac catheterization
•9. Receiving other clinical trials monitor
•10. Patients can’t receive therapy or examination in this study
•11. Blood sugar and blood pressure control poorly (SBP>160 mmHg, AC F/S>200mg/dL and PC F/S>300mg/dL)
•12. Not suitable for cardiac catheterization
•13. Contraindications to G-CSF or HBO
•14. Patient is unconscious
•15. Untreated active infection
•16. Those who undergo major surgery within one month
•17. Patients with stroke or unstable angina within 3 months
•18. Unsuitable candidates after initial evaluation
•19. Those of unsuitable for HBO therapy, e.g., active pulmonary tuberculosis, spontaneous pneumothorax etc
•20. TcOP2 =46mmHg

发起方

Ministry of Science and Technology (Taiwan)