This clinical trial to study the Safety and Efficacy of Autologous Mesenchymal stem cells in critical limb ischemia.
If the participant voluntarily agrees to participate in the clinical trial before registration, the investigator conducts a screening test to evaluate the participant's suitability. A participant that satisfies all inclusion and exclusion criteria is assigned a test group(2-time injection group). Participants conduct cell therapy within 30 days after bone marrow aspiration, and will re-inject autologous mesenchymal stem cells within 30 days after first injection. Participants will make a total of 5 hospital visits after registration, and Safety and Efficacy will be evaluated based on a fixed procedure on every visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Appearance: White cell suspension is filled in a clear plastic syringe, and fixed with an occlude on the prefilled syringe tip Main ingredient: Autologous bone marrow-derived mesenchymal stem cells Dosage: 50,000,000 cells/10ml, 2-time injection Storage: An airtight container, 20\~25℃ Injection Method: Intramuscular
Ankle Brachial Pressure Index, ABPI
Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference of between the two visits(Screening and 6 month post treatment) before and after treatment.
Time frame: 6 months after BM-MSC therapy
Collateral vessel formation on digital subtraction angiography (DSA)
Analyze the difference of pre and post treatment using McNemar test for homogeneity test.
Time frame: 6 months after BM-MSC therapy
Difference of Wound size
Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference of pre and post treatment Healing of ulcerations (change in size of ulcers) or reduction of ulcer area in the target limb.
Time frame: 6 months after BM-MSC therapy
Improved transcutaneous oxygen pressure (TCPO2)
Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference of pre and post treatment transcutaneous oxygen pressure (TCPO2).
Time frame: 6 months after BM-MSC therapy
Pain on the Visual Analogue Scale(VAS)
Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference of pre and post Visual Analogue Scale(VAS). Visual Analogue Scale(VAS): Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
Time frame: 6 months after BM-MSC therapy
Reduced limb amputation
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Described and define as minor amputation is below midtarsal level, major amputation is more than midtarsal level.
Time frame: 6 months after BM-MSC therapy
Temperature change on thermography
Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference of pre and post thermography.
Time frame: 6 months after BM-MSC therapy
Dose about using analgesic medicine
Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference between pre and post dose of the using analgesic medicine.
Time frame: 6 months after BM-MSC therapy
Change in Rutherford classification
Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference of pre and post Rutherford classification. Rutherford classification: commonly used clinical staging system for describing peripheral arterial disease. Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Time frame: 6 months after BM-MSC therapy
Frequency about using analgesic medicine
Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference between pre and post frequency of the using analgesic medicine.
Time frame: 6 months after BM-MSC therapy