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

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

15

The average age of the 15 enrolled cases was 43.7 years old, with 6 males and 9 females. The causes of injury were scald burns in 10 cases and flame burns in 5 cases, with an average total burn surface area of 7.0%.

In the Allo-JaCE03 clinical trial, consent was obtained from 18 cases. Among them, 15 cases were investigated for eligibility, and all of which were registered as study participants. Cases applied with Allo-JaCE03 totaled 14, with 12 cases completing evaluations and 2 cases ending without completing evaluations.

No adverse events of concern were observed.

The primary endpoint was the epithelialization rate at the Allo-JaCE03 application site on the 7th day after initial application. This parameter demonstrated a statistically significant improvement in clinically relevant efficacy (p=0.0123, Student's t-test) .

The primary endpoint was the epithelialization rate at the Allo-JaCE03 application site on the 7th day after initial application. This parameter demonstrated a statistically significant improvement in clinically relevant efficacy (p=0.0123, Student's t-test) . No adverse events of concern were observed.

Sept. 17, 2024

No

None. It is not being prepared.

https://jrct.mhlw.go.jp/latest-detail/jRCT2052210214

Hayashi Shigeaki

Japan Tissue Engineering Co., Ltd.

6-209-1 Miyakitadori, Gamagori, Aichi

jtec-info@jpte.co.jp

Hayashi Shigeaki

Japan Tissue Engineering Co., Ltd.

6-209-1 Miyakitadori, Gamagori, Aichi

+81-533-66-2140

jtec-info@jpte.co.jp

Complete

April. 01, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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.

Both

deep dermal burn (DDB)

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.

burn, deep durmal burn, DDB, deep partial-thickness burn, deep partial thickness burn, deep second degree burn, deep 2nd degree burn

D002056

Epithelialization rate of Allo-JaCE03 application site on 7th day after the initial application

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

+81-75-751-4389

Mar. 10, 2022

none