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Reconstruction of vascular access with vascular graft from autologous dermal fibroblasts

Reconstruction of vascular access with vascular graft from autologous dermal fibroblasts

Noguchi Mitsuru

Itoh Manabu

Saga University Hospital

5-1-1, Nabeshima, Saga-shi, Saga-ken, Japan

itomana@cc.saga-u.ac.jp

Itoh Manabu

Saga University Hospital

5-1-1, Nabeshima, Saga-shi, Saga-ken, Japan

+81-952-34-2345

itomana@cc.saga-u.ac.jp

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Both

end-stage renal failure

Transplant a vascular graft from autologous dermal fibroblasts

Rate of adverse event

Primary and secondary patency period

Recruiting

+81-533-66-2226

July. 18, 2019