CLI(Critical limb ischemia) (Buerger disease)
Conditions
Sponsors
Kyoto Prefectural University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age is aged 20 and over and a less than 80 years old patient. 2) Sex does not ask. 3) Buerger disease with Fontaine classification III or IV. 4) The affected side SPP at the time of registration is 30 mmHg. 5) The patient by whom it was checked that I enforce all the standard treatments by which insurance was carried out, and there is no recovery. 6) I am related with the profits and the disadvantage which arises by receiving a cell transplant, and the profits and the disadvantage which arise by not receiving a cell transplant,the patient who is given to sufficient explanation with a consent explanatory note document and from whom the document consent to test participation is acquired based on the patient's himself intention (those who need care and care need an understanding and consent of a family for the person himself/herself).
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 |
|---|---|
| The amount of change of SPP from registration to 6 months after implantation | — |
Countries
Japan
Contacts
Public ContactKenji Yanishi
Kyoto Prefectural University School of Medicine Cardiovascular Medicine
Outcome results
None listed