Safety assessment of dried allogeneic cultured epidermis in skin defects

JRCT ID: jRCTs052190079

Registered date:05/12/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: skin defects
• Date of first enrollment: 15/04/2020
• Target sample size: 6
• Study type: Interventional

Intervention(s)

Number of transplants: Once in principle. However, taking into consideration of the condition for the wound site after transplantation, multiple transplantation is admitted.
Transplant volume: Up to 20 sheets per case.
Postoperative management: Managing in the same way as ordinary skin graft and autologous cultured epidermal transplantation.

Outcome(s)

• Primary Outcome: Safety (Adverse events and malfunction)

Secondary Outcome

1. Closure rate of transplantation site on day 14 after grafting(%)
2. exudate level

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients with skin defect whose diameter is over 3 cm and whose body surface area is under 10%.

Exclude criteria

1. Patients who are apparently infected with applied injuries.
2. Patients with hypersensitivity to antibiotics such as penicillin, kanamycin, streptomycin and amphotericin B. Patients who have a history of hypersensitivity to penicillin antibiotics and aminoglycoside antibiotics.
3. Patient with allergy to animals (bovine, mouse, pig).
4. Patients with malignant cutaneous tumors, patients with suspected malignant cutaneous tumors or patients with a history of malignant cutaneous tumors.
5. Pregnant women, lactating women and patients who may possibly be pregnant or who have preference for pregnancy during the study period
6. Patients participating in other clinical trials at the time of consent acquisition and patients planning to participate in other clinical trials during the study participation.

Related Information

• Primary Sponsor: Sakamoto Michiharu
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development (AMED)