A clinical trial of a novel skin reconstruction treatment for GCMN.

Phase 2

• Conditions: Congenital giant melanocytic nevus

• Registration Number: JPRN-jRCT2052210044
• Lead Sponsor: Morimoto Naoki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

1. Patients with a giant congenital melanocytic nevi which is determined to be unable to be resected with standard treatments including primary closure, tissue expansion, and skin grafting.
2. Pathological confirmation of the presence of nevus cells in the deep dermis with skin biopsy.
3. Patients who can undergo surgery under general or local anesthesia.
4. Patients who are over 6 months of age at the time of consent acquisition.
5. Patients provided written informed consent for the clinical trial participation.

Exclusion Criteria

1. Patients with extensive scarring from previous therapies in whom the engraftment of the inactivated nevus is not expected.
2. Patients receiving systemic immunosuppressants or steroids.
3. Patients with allergy to penicillin, kanamycin, streptomycin, amphotericin B, or with a history of allergy to penicillin and aminoglycoside antibiotics.
4. Patients with allergy to cows, mice, or pigs.
5. Patients with a hystory of malignant skin tumors or with suspected malignant skin tumors.
6. Patients participating in other clinical trials within the last 3 months.
7. Patients who had participated in this clinical trial and been transplanted inactivated autologous nevus.
8. Patients who are judged by the investigators to be inappropriate for participation in this clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Engraftment of JACE and inactivated nevus tissue evaluated at 8 weeks after implantation of JACE.

Secondary Outcome Measures

Name	Time	Method
1. Safety (adverse events and malfunctions)<br>2. Efficacy (skin grafting ratio = A/B; A, the area of skin grafts required for the reconstruction of the site where the inactivated autologous nevus did not engrafted; B, the area of reimplanted inactivated autologous nevus)<br><br>Tertiary, the color change between the target nevus and the reconstructed skin was evaluated using Commission Internationale de I'Eclairage (CIE) L*a*b*.