Clinical study of autologous noncultured epidermal cell transplantation for leucodelma treatment

Completed

• Conditions: stable vitiligo

• Registration Number: jRCTc050190126

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-02
• Study First Submitted: 2020-03-30
• Last Update Posted: 2022-05-30

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Men and women aged over 20 years old with a diagonosis of stable vitiligo who visited the department of dermatology Osaka University Hospital and who signed a written informed consent by themselves after receiving the explanation of clinical study.

Exclusion Criteria

Apparently unstable patients defined as new areas of depigmentation or enlarging areas of depigmentation within the last 12 months. Patients with treatment of steroid, active vitamin D3, calcineurin inhibitor and light radiation therapy within the 4 weeks befor registration. History of hypertrophic scar, keloid scars or presence of Koebner's phenomenon Patients with allergies to antibiotics and local anaesthetics Patients with tape rash Pregnant women, lactating women and patients who deaire pregnancy during clinical studies. Positive serology of Hepatitis B and C, HIV, HTLV-1 Patients who are participating in other clinical studies including interventions or non-interventions such as observation studies. Investigators judge the patiens should not paticipate in the study for any reason

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
repigmentation rate	before, 3 months after and 6 months after the operation	Evaluation of repigmentation rate of: - cell transplantation area (test site); - suction blister transplantation area (comparison site); - non-treated area (control site); Method: calculating the area of images taken by digital camera
wound areas observation		Observation of the wound areas of: - donor site; - test site; - comparison site; - control site; Purpose: safety evaluation

Secondary Outcome Measures

Name	Time	Method
Evaluation of color matching	before, 3 months after and 6 months after the operation	Evaluation of color matching (melanin and hemoglobin) on the test site, comparison site, control site and peripheral healthy site by the Mexameter.
Incidence of adverse effects	before, 3 months after and 6 months after the operation	Incidence of adverse effects like infection, scarring and hemorrhoids resulting from the regenerative medicine as a safety evaluation.