ISRCTN80181257
Terminated
未知
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 sites40 target enrollmentOctober 3, 2017
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ministry of Science and Technology (Taiwan)
- Enrollment
- 40
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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