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. 2023 Jun 30;24:167–173. doi: 10.1016/j.reth.2023.06.012

Table 1.

Study eligibility and exclusion criteria.

Eligibility Criteria:
  • 1

    Giant congenital melanocytic nevi that could not 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 dermal layer

  • 3

    Patients ≥6 months of age who could undergo surgery under general or local anesthesia

  • 4

    Provision of written informed consent

Exclusion Criteria:
  • 1.

    Patients with extensive scarring from previous therapies, where engraftment of the inactivated nevus was not expected

  • 2.

    Patients receiving systemic immunosuppressants or steroids

  • 3.

    Patients with allergies to penicillin, kanamycin, streptomycin, and amphotericin B or a history of allergy to penicillin and aminoglycoside antibiotics

  • 4.

    Patients allergic to cows, mice, or pigs

  • 5.

    Patients with a history of malignant skin tumors or with suspected malignant skin tumors

  • 6.

    Patients who had participated in other clinical trials within the last 3 months

  • 7.

    Patients who previously participated in this clinical trial and underwent transplantation for an inactivated autologous nevus

  • 8.

    Patients judged by the investigators as being inappropriate for participation in the clinical trial