None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : About 30 ml of peripheral blood is collected from the patient registered in the Korean study, cells are collected from the peripheral blood, and induced pluripotent ste
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 19 years or older 2) Patients with lower extremity artery disease, Rutherford classification table 3, 4, 5, 6 (Fontaine’s stages IIb, III, IV) patients receiving vascular interventional therapy Or, induce successful reperfusion through bypass surgery. If you are unable to do so or do not meet the indications 3) If you can sign the consent form and comply with the requirements for clinical research 4) Patients with adequate hematologic function and end-organ function confirmed by the following laboratory test values: -ANC=1.5*109 /L(1,500/uL)withoutgranulocytecolony-stimulatingfactor(G-CSF) support - WBC count =3,000/uL - Platelet count =75,000/uL without transfusion - Hemoglobin =8g/dL (patients may be transfused or receive erythropoietic treatment to meet this criterion) - AST, ALT, and ALP <3x ULN - Total bilirubin =1.5 x ULN - Serum creatinine =1.5xULN or Creatinine clearance = 30ml/min - PT/INR and PTT =1.5xULN (INR is stable in patients receiving anticoagulant therapy) case) 5) Patients with life expectancy of more than 1 year
Exclusion criteria
Exclusion criteria: 1) Patients who had undergone angioplasty or bypass procedures to the lower extremity subject to cell transplantation within 1 month prior to screening visit (does not apply to the case of the contralateral limb) 2) Patients with clinically significant active infections or severe uncontrolled systemic diseases (as assessed by the investigator prior to enrollment) 3) Patients who have received other investigational drugs within 3 months prior to screening 4) Patients with a history of malignancy within 5 years prior to participation in the clinical trial 5) Patients currently receiving immunosuppressive therapy, chemotherapy, or radiotherapy 6) Women who are pregnant or breastfeeding, or women of childbearing potential not protected by effective contraception 7) Any other individuals deemed by the investigator to be unsuitable for participation in this clinical study 8) Patients who have previously participated in a clinical trial involving cell therapy or have received cell infusions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessment: Adverse events, serious adverse events, clinically significant laboratory tests Outcome, specific vital sign measurements | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy evaluation: skin perfusion pressure;Efficacy evaluation: ankle-brachial index (ABI index);Efficacy evaluation:intratissue oxygen partial pressure;Efficacy evaluation:patient's Measurement of the degree of walking disability;Efficacy evaluation: measurement of the number and size of ulcers;Efficacy evaluation: neovascularization in the cell treatment area | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung-Guk Ko
Yonsei University Health System, Severance Hospital
Outcome results
None listed