jRCT ロゴ

臨床研究等提出・公開システム

Top

Japanese

Mar. 02, 2020

April. 03, 2025

jRCTb040190122

Efficacy of cultured epidermal autograft in the treatment of vitiligo, refractory scar and refractory skin ulcer. (Efficacy of cultured epidermal autograft for skin disease)

Cultured epidermal autograft in the treatment of leukoderma, refractory scar and refractory skin ulcer.

Matsukawa Noriyuki

Toriyama Kazuhiro

Nagoya City University Hospital

1-Kawasumi, Mizuho-cho, Mizuho-ku,Nagoya, Aichi

+81-52-851-5511

toriyama@med.nagoya-cu.ac.jp

Ito Sanae

Nagoya City University

1-Kawasumi, Mizuho-cho, Mizuho-ku,Nagoya, Aichi

+81-52-853-8348

ncu_sai@med.nagoya-cu.ac.jp

60

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

(1) The person who has vitiligo, refractory scar and refractory skin ulcer more than six months
(2) The person who understand and consent this clinical trial. The necessity of written consent by legal representatives (parents, guardians) as well as by the principal when the person is restricted in the age (from 16 to 20). Additionally, The necessity of written consent by legal representatives (parents, guardians) when the person is under 16 year od age.
(3) Negative in the prescribed infection inspection (hepatitis B, hepatitis C, syphilis, human immunodeficincy virus, adult T cell leukemia)

(1) Allergy to antibiotic (penicillin, kanamycin, streptomycin, amphotericin B), medical history of allergy to penicillins and aminoglycoside.
(2) Allergy to animals (cow, mouse, pig)
(3) Suspected , present illness and medical history of skin malignant tumor
(4) Difficulty of participation due to mental disorder
(5) Pregnant, lactating woman and possibility of pregnancy
(6) Skin Infectious disease requiring systemic medical treatment
(7) Positive in the prescribed infection inspection (hepatitis B, hepatitis C, syphilis, human immunodeficincy virus, adult T cell leukemia)
(8) Not suitable for this clinical trial from the view oint of the doctors who perform regenerative medicine

No limit
No limit

Both

vitiligo, refractory scar and refractory skin ulcer

1) Taking healthy skin
2) Skin lesion is erased
3) Cultured epidermal autograft

Rate of efficiency of improvement of diseases.
The degree of efficiency is estimated by image analyses at the one of the following: extremely effective (100 - 70 %), effective (70- 50 %), slightly effective (50- 10 %), poorly effective (10- 0 %), uneffecive (0 %).

Quantitative evaluation
1) Spectral colorimeter,
2) skin viscoelasticity

Aug. 30, 2017
Aug. 30, 2017

Recruiting

Gamagori City Hospital Certified Committee Regenerative Medicine
1-1 mukaida hirata-cho gamagori-shi, Aichi

+81-533-66-2226

saisei@city.gamagori.lg.jp
Approval

Mar. 15, 2017

46-16-0014
Nagoya City University Graduate School of Medical Sciences and Nagoya City University Hospital Institutional Review Board

History of Changes

No Publication date
9 April. 03, 2025 (this page) Changes
8 Mar. 07, 2025 Detail Changes
7 July. 07, 2023 Detail Changes
6 Oct. 14, 2022 Detail Changes
5 April. 07, 2022 Detail Changes
4 Mar. 29, 2022 Detail Changes
3 April. 07, 2021 Detail Changes
2 Oct. 26, 2020 Detail Changes
1 Mar. 02, 2020 Detail