None listed
Conditions
Interventions
Biological/Vaccine : - Dose : 1x10^7 cells/injection
- Injection Route : inject to 20 different sites arround tibial artery and fibular artery which situated below the knee joint of ischemic limb
- In
Sponsors
Adult Stem Cell Research Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Among the patients who has Peripheral arterial occlusive disease caused by Buerger's disease and arteriosclerosis and at the same time their ABI (resting ankle-brachial index) is lower than 0.9 follow by hemodynamical definition. (1) Rutherford’s (Fontaine’s stages IIb, III, IV) 3, 4, 5, and 6 (reference 12) patient who has at least 3months claudification or pain during a rest or gangrene or ulcer with irrespective period. (but, patient who does not get better with medication and improvement of life style during 3months will be a candidate for Category 3) (2) patient who is Inapplicable by Bypass surgery or percutaneous transluminal angioplasty; In case of patients with bypass surgery or percutaneous transluminal angioplasty cannot be applied; By doctors from Vascular surgery, cardiovascular medicine, and department of radiology determines bypass surgy and percutaneous transluminal angioplasty is not applicable through reffering system. 2) Person who agree to the agreement by themselves by fully explained about purpose, content and charateristic of trial medicine before participate
Exclusion criteria
Exclusion criteria: (1) Under 18 (2) Medical history of allergy or anaphylatic shock (3) Medical history of Autoimmune disease (rheumatoid arthritis, systemic lupus erythematosus, ....)or Hypercoagulated disease (4) Having the bypass surgery or angioplasty of artery or aorta within first two months of visit (5) Medical history of being treated with other cell therapy of gene therapy (6) Having a Heart failure of NYHA functional classification III & IV (reference 13) (7) Having unstable angina (8) Medical history of acute ST-segment elevation with myocardial infarction within a first month of visit (9) Medical history of transient ischemic attack or stroke within a first month of visit (10) Severe valvular heart disease (11) Uncontrolled diabetes (HbA1c > 8%) (12) Renal failure (creatinine > 2.5) (13) Medical history of having malignant tumor or being treated with radiation therapy or chemotherapy within five years (14) Pregnant or lactating or possible pregnancy women who is free to medically accepted method of birth control (15) Having cognitive dysfunction and walking disability (16) Having infectious disease (17) Severe disease patient who might die during follow-up period because of their one year life expectancy (18) WBC 15,000 (19) AST (GOT) > 100 or ALT (GPT) > 100 (20) Having gait disturbance by neurology cause (21) Disqualified as a suitable subjest by tester (22) Uncontrolled hypertension (23) Currently receiving immunosuppressive therapy or chemical therapy (24) Hematodyscrasia patient with hemorragic diathresis (25) Participated in other clinical trials (26) Patient with Hb<10 and thrombocyte<100,000
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Effect | — |
Secondary
| Measure | Time frame |
|---|---|
| Scale for gauging changes in clinical status | — |
Countries
Korea, Republic of
Contacts
Public ContactDong-Ik Kim
Samsung Medical Center
Outcome results
None listed