A clinical trial of dried allogeneic cultured epidermis (Allo-JaCE03) for deep dermal burn

JRCT ID: jRCT2052210214

Registered date:31/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: deep dermal burn (DDB)
• Date of first enrollment: 23/06/2022
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Allo-JaCE03 will be applied to the DDB wound followed by debridement and/or cleaning according to standard practice. In order to maintain the coverage with Allo-JaCE03, the investigators can determine the additional application of Allo-JaCE03.

Outcome(s)

• Primary Outcome: Epithelialization rate of Allo-JaCE03 application site on 7th day after the initial application

Secondary Outcome

1) Epithelialization rate of Allo-JaCE03 application site on 14th and 21st day after the initial application
2) Subject ratio of complete epithlialization until 21st day after the initial application
3) Wound condition (wound infection, exudate volume)
4) Pain assessment

Key inclusion & exclusion criteria

• Age minimum: >= 8age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1) Patients with deep dermal burn (DDB) wounds of 40 cm^2 or larger
2) Patients with an age of >=8 years and =< 75 years when signed and dated informed consent, who can sign the informed consent forms by themselves, and whose legal representative can sign the informed consent if the patient is underage

Exclude criteria

1) Patients with 20%TBSA or more of burn area
2) Patients with airway burns or soft tissue damage, patients caused by electric shock, etc., who determined by the investigator difficult to participate in the study.
3) Patients diagnosed underlying diseases such as diabetes, heart failure, liver failure, renal failure, neurological disease, or patients with systemic administrations of immunosuppressants or steroids (corticosteroids) , which may have potential interference in the wound healing.
4) Patients requiring sedation management
5) Patients with malignant cutaneous tumors, patients with suspected malignant cutaneous tumors or patients with a history of malignant cutaneous tumors in 5 years
6) 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.
7) Patients with allergy to animals (bovine, mouse, pig)
8) Pregnant women, lactating women and patients who may possibly be pregnant or who have preference for pregnancy during the study period
9) Patients participated in other clinical trials or clinical researches in 4 months at the time of eligibility confirmation.
10) Patients participating in other clinical trials or clinical researches at the time of consent acquisition and patients planning to participate in other clinical trials or clinical researches during the study participation.
11) Patients determined by the investigator difficult to participate in the study.

Related Information

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