A multicentre, intra-patient randomised controlled Phase III study to confirm the efficacy and safety of denovoSkin™, a bilayer engineered collagen-based skin graft composed of autologous fibroblasts and keratinocytes, for the treatment of patients with deep partial and full-thickness burns

Phase 1

• Conditions: Deep partial and full-thickness burns; MedDRA version: 20.0Level: LLTClassification code: 10006634Term: Burn Class: 10022117; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: CTIS2023-507717-94-00
• Lead Sponsor: Cutiss AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-28
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Patients with deep partial or full-thickness thermal burns of =20% TBSA for which excision and SOC (STSG) are clinically indicated, Patients of either sex aged =12 years, Signed informed consent from the patient and/or legally authorised representative

Exclusion Criteria

Burn wound areas solely located on the head and neck (i.e., test and control areas must NOT be located on head/neck), Women of child-bearing potential not using highly effective method(s) of birth control (i.e., with low failure rate <1% per year) throughout the study and/or unwilling to be tested for pregnancy. A negative serum beta-human chorionic gonadotropin (ß-hCG) test is required on the day of grafting, Patient is the Investigator, one of his/her family members, employees, and other dependent persons, Patients with serologic evidence of active hepatitis B virus infection (i.e., positive for Hepatitis B surface antigen or immunoglobulin M total Hepatitis B core antibody), active hepatitis C infection (hepatitis C virus antibody positive),positive human immunodeficiency virus serology, or positive Treponema pallidum serology, Patients with known underlying or concomitant medical conditions that, in the opinion of the Investigator, has the potential to significantly delay wound healing, e.g., glycated haemoglobin (HbA1c) =53 mmol/mol and/or systemic skin and connective tissue diseases, Patients with pre-existing coagulation disorders as defined by international normalised ratio outside its normal value, a prothrombin time greater than the upper limit of normal, and fibrinogen less than the lower limit of normal prior to the current hospital admission, Patients with a history of clinically significant hypersensitivity to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen, Previous treatment with denovoSkin™, Participation in any clinical interventional study within 60 days prior to the first IMP administration in case of monoclonal antibodies and <30 days for all other IMPs, Patients unwilling or unable to comply with procedures required in this clinical study protocol, Pregnant or lactating women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: First Secondary Objectives: • To confirm the donor-site sparring effect of denovoSkin™ by comparing the difference of the expansion ratio between the IMP and STSG • To confirm the limitation of scar contracture by comparing the size of the area grafted with IMP and STSG over time, Other Secondary Objective: • To confirm the progression and quality of the burn wound and donor site wound healing after denovoSkin™ grafting as compared to meshed STSG;Primary end point(s): A composite endpoint whereby success is defined by meeting both of the following criteria: • Wound closure defined as at least 95% epithelialisation at 10 weeks post-grafting • POSAS v2.0 overall opinion of at most 5, based on the observer evaluation (observer part of POSAS) at 6 months post-grafting;Main Objective: To confirm the efficacy and functionality of denovoSkin™ in achieving wound closure and reducing scarring in patients with deep partial and full-thickness burns as compared to STSG