Application of autologous peripheral blood-derived stem cell/progenitor cell (CD34+) + stem cells and hyperbaric oxygen therapy for patients with severe limb ischemia
- Conditions
- Severe limb ischemiaCirculatory System
- Registration Number
- ISRCTN80181257
- Lead Sponsor
- Ministry of Science and Technology (Taiwan)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method imb salvage, defined as alive without amputation within 12 months
- Secondary Outcome Measures
Name Time Method