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JAPANESE
国立保健医療科学院
JMACCT ID: JMA-IIA00103

Registered date:16/11/2012

A clinical study of cultured epithelial autografts (CEA) for patients with giant congenital melanocytic nevi

Basic Information

Recruitment status Completed
Health condition(s) or Problem(s) studiedGiant congenital melanocytic nevi
Date of first enrollment30/11/2012
Target sample size10
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention type:DEVICE. Intervention1:Cultured epithelial autografts (CEA), Dose form:DEVICE, Route of administration:CUTANEOUS, intended dose regimen:The CEA are placed onto lesions removed nevi. If the lesions need additional grafting, additional CEA are placed onto grafted lesions at 3rd week after first grafting..

Outcome(s)

Primary OutcomeThe case that epithelialization rate is 95% or greater after CEA grafting without any other treatments is evaluated as 'effective'.. Timepoint:The evaluation and observation period is until 12 weeks after first CEA grafting. .
Secondary Outcome1.Epithelialization rate at 8th week and 12th week after first CEA grafting 2.Final epithelialization rate after CEA grafting. 3.Number of days between first CEA grafting and completing epithelialization 4.Length of hospital stay (from first CEA grafting to permission for discharge). Timepoint: 1. At 8th week and 12th week after first CEA grafting 2. When the evaluation and observation period is over. 3. At the time to complete epithelialization 4. At the time of discharge.

Key inclusion & exclusion criteria

Age minimum>=3 MONTHS
Age maximumNo Limit
GenderBOTH
Include criteria1.The patient with giant congenital melanocytic nevi 2.The giant congenital melanocytic nevi cover approximately 5 % or greater of the body surface area. 3.The patient is the age of 3 months or older at the time of CEA grafting.
Exclude criteria1.The patient with hypersensitivity to penicillin, kanamycin, streptomycin, amphotericin B and/or the patient has a history of hypersensitivity to penicillin antibiotic and aminoglycoside antibiotic 2.The patient has an allergy to cattle, mice and/or swine 3.The patient with cutaneous malignant tumor, the patient suspected of cutaneous malignat tumor, the patient has a history of cutaneous malignant tumor 4.The patient has an experience with CEA 5.The patient participated in other clinical trials in the past 30 days, the patient will or may participate other clinical trials during the trial. 6.The patient who is considered ineligible by the principal investigator or subinvestigator.

Related Information

Contact

public contact
Name Nanako Nagafuchi
Address Division of Plastic Surgery,2-10-1, Okura, Setagaya-ku, Tokyo, 157-8535, Japan
Telephone +81-3-5494-7298
E-mail nagafuchi-n@ncchd.go.jp
Affiliation National Center for Child Health and Development
scientific contact
Name Tsuyoshi Kaneko
Address Division of Plastic Surgery,2-10-1, Okura, Setagaya-ku, Tokyo, 157-8535, Japan
Telephone +81-3-3416-0181
E-mail
Affiliation National Center for Child Health and Development