JPRN-jRCTb070190033
Recruiting
Phase 1
Reconstruction of vascular access with vascular graft from autologous dermal fibroblasts
Itoh Manabu0 sites3 target enrollmentNovember 7, 2019
Conditionsend-stage renal failure
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- end-stage renal failure
- Sponsor
- Itoh Manabu
- Enrollment
- 3
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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