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

Phase 3

• Conditions: deep dermal burn (DDB); burn, deep durmal burn, DDB, deep partial-thickness burn, deep partial thickness burn, deep second degree burn, deep 2nd degree burn; D002056

• Registration Number: JPRN-jRCT2052210214
• Lead Sponsor: Hayashi Shigeaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion 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

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified