CLI(Critical limb ischemia) (ASO, Buerger disease, Collagen disease)
Conditions
Interventions
Therapeutic Angiogenesis using Autologous BMMNCs(Bone-Marrow Mononuclear Cell) for CLI.
Sponsors
Kyoto Prefectural University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1,Adaptation standard : An adaptation standard belongs to Fontaine classification III, degree of IV, and Rutherford classification II degree 4 group, III degree 5 group, and six groups. At the time of quiet At the patient who has sharp pain or an ischemic ulcer, they are medical and surgery. Patient by whom there is no adaptation of the-like blood circulation reconstruction way, and cutting will be expected in the future. A blood vessel rebirth does not have complications which can serve as an aggravation factor, but conflicts with exclusion criteria. What is not carried out. 2,Selection-criterion: 1) Age is aged 20 and over and a less than 80-year-old patient. Sex does not ask. 2) The patient who fulfills one conditions of the followings by the patient to whom the obstacle of the everyday life is remarkably carried out by the serious illness leg ischemia of Fontaine III-IV. A) A living guidance, medication, percutaneous-transluminal-angioplasty way, and bypass hand including prohibition of smoking Way - Patient by whom recovery is not seen in the cure from the former called a nerve knot block etc. B) it is judged by a vascular surgeon and the circulatory organ physician that there is no adaptation of a blood circulation reconstruction way -- the patient to whom cutting will be obliged from now on. 3) A document fully explains the complications, the profits, and the disadvantage by the effect, side effects, and operation which arises in a cell transplant, and it is based on an understanding and consent of the patient's himself will, and a family, and is cell transplant medical treatment. Patient whom I wish and by whom written consent is got.
Exclusion criteria
Exclusion criteria: Exclusion-criteria: 1. Even if the disease and the way type are suitable, or informed consent is not obtained from a patient, it is feelings consideration to a patient family. When I am required and it is difficult to be adapted. 2. When diagnosed as malignant tumor by inspections. 3. When it has ischemic cardiopathy and blood circulation reconstruction is not performed. 4. Serious illness diabetic retinopathy with no treatment. 5. When it has serious infection. 6. When critical impaired liver function and renal dysfunction (maintenance dialysis patient removes) exist. 7. When serious anemia which needs blood dyscrasia and transfusion with white corpuscle reduction, critical decrease of platelets, etc. exists. 8. Nursing mother when there are under pregnancy and possibility of pregnancy. 9. Simultaneous with the final examination, or those to the final examination that incorporated and participated in other clinical tests of trial drug or products on the market (medical equipment is included) within 30 days. 10. When the serious anemia which needs blood dyscrasia and transfusion with white corpuscle reduction, a critical decrease of platelets, etc. exists. 11. There are other acute and chronic medical [ serious ] and mental state, and abnormalities in a clinical laboratory test result. Danger may increase by test participation. The patient who may have on the interpretation of a test result. The patient to whom the examination responsibility (assignment) doctor judged the participation in the final examination to be unsuitable. 12. In addition, when a family doctor and a medical specialist judge it as a stop.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of rest pain using Numerical Rating Scale | — |
Countries
Japan
Contacts
Public ContactKenji Yanishi
Kyoto Prefectural University School of Medicine Cardiovascular Medicine
Outcome results
None listed