An investigator-initiated clinical trial of a novel skin reconstruction treatment for giant congenital melanocytic nevi using KUPRS-01, a specialized medical device composed of a high hydrostatic-pressure machine and a sealed container. - HP-GIANT

Morimoto Naoki0 个研究点目标入组 3 人开始时间: 2021年7月2日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

Morimoto Naoki