Cultured epidermal autograft in the treatment of leukoderma, refractory scar and refractory skin ulcer.
- Conditions
- vitiligo, refractory scar and refractory skin ulcer
- Registration Number
- JPRN-jRCTb040190122
- Lead Sponsor
- Toriyama Kazuhiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of efficiency of improvement of diseases. <br>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 %).
- Secondary Outcome Measures
Name Time Method Quantitative evaluation<br>1) Spectral colorimeter,<br>2) skin viscoelasticity