end-stage renal failure
Conditions
Interventions
Transplant a vascular graft from autologous dermal fibroblasts
Sponsors
Itoh Manabu
Nakayama Koichi
Cyfuse Biomedical K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >=20 2. Subjects with vascular access for hemodialysis which is judged to need replacement or bypass of stenosis, or replacement of aneurysm 3. Judged appropriate for this trial from a result of pre-test 4. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects with active infection or medical history 2. Subjects with positive for syphilis, HBs antigen, HCV antibody, HIV gene, HTLV-1 antibody, or parvovirus B19 antibody in pre-test. But, if antibody is positive, judged infectivity 3. Subject with severe heart failure, or severe liver disorder 4. Subjects with acute phase myocardial infarction, or cerebral infarction 5. Subjects with active tumor, or a history of malignant tumor (excluding intraepithelial neoplasia) within 5 years 6. Subjects with drug dependence, or alcohol dependence 7. Subjects who participated in other clinical research within 3 months 8. Subjects who have a history of drug hypersensitivity (including aminoglycosides and polyene antibiotics) 9. Subjects with allergies to animals (cow) and metals 10. Subjects with a history of anaphylactic reaction 11. Pregnancy, breast feeding or intention to become pregnant 12. Judged inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary and secondary patency period | — |
Countries
Japan
Contacts
Public ContactManabu Itoh
Saga University Hospital
Outcome results
None listed