Reconstruction of vascular access with vascular graft from autologous dermal fibroblasts

Phase 1

Recruiting

• Conditions: end-stage renal failure

• Registration Number: JPRN-jRCTb070190033
• Lead Sponsor: Itoh Manabu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 3

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
11. Pregnancy, breast feeding or intention to become pregnant
12. Judged inappropriate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of adverse event

Secondary Outcome Measures

Name	Time	Method
Primary and secondary patency period