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

JRCT ID: jRCT2052210044

Registered date:02/07/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Congenital giant melanocytic nevus
• Date of first enrollment: 04/08/2021
• Target sample size: 3
• Study type: Interventional
• Intervention(s): Reimplantation of high-hydrostatic pressurized nevus tissue as a cell-inactivated autologous scaffold for the regenaration of the dermis, and secondary implantation of cultured epithelial autografts (JACE) on the regenarated dermis.

Outcome(s)

• Primary Outcome: Engraftment of JACE and inactivated nevus tissue evaluated at 8 weeks after implantation of JACE.

Secondary Outcome

"1. Safety (adverse events and malfunctions)
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)

Tertiary, the color change between the target nevus and the reconstructed skin was evaluated using Commission Internationale de I'Eclairage (CIE) L*a*b*."

Key inclusion & exclusion criteria

• Age minimum: >= 6month old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Morimoto Naoki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development