Phase III Study with an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents

Phase 3

Recruiting

• Conditions: Burns
• Interventions: Biological: denovoSkin(TM); Other: STSG

• Registration Number: NCT06745557
• Lead Sponsor: CUTISS AG

Brief Summary

This multicentre phase III clinical trial will target adults and adolescents of 12 years and older with severe burns 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 split-thickness skin.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-09
• Study Start: 2024-12-13
• Study First Submitted QC: 2024-12-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-12-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients with deep partial or full-thickness thermal burns of ≥20% total body surface area (TBSA) for which excision and standard of care (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)
• Patients eligible to have all areas autografted in a single surgery or significantly earlier than the end of the manufacturing period of denovoSkin™, for whom the application of denovoSkin™ would delay the standard of care therapies
• Patients with serologic evidence of active hepatitis B virus (HBV) infection (i.e., positive for Hepatitis B surface antigen [HbsAg] or immunoglobulin M total hepatitis B core antibody [anti-HBc]), active hepatitis C infection (hepatitis C virus [HCV] antibody positive), positive human immunodeficiency virus (HIV) serology, or positive Treponema pallidum serology assessed as per local standard of care; cured hepatitis C (defined as documented treatment and negative viral load) is not an exclusion
• 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 (INR) outside its normal value, a prothrombin time (PT) 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 and it's derivatives (e.g. gelatine)
• 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
• 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 (β-hCG) test is required on the day of grafting
• Patient is the Investigator, one of his/her family members, employees, and other dependent persons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Option 1	denovoSkin(TM)	Location A is the experimental area and Location B is the control area
Option 1	STSG	Location A is the experimental area and Location B is the control area
Option 2	denovoSkin(TM)	Location A is the control area and Location B is the experimental area
Option 2	STSG	Location A is the control area and Location B is the experimental area

Primary Outcome Measures

Name	Time	Method
A composite endpoint whereby success is defined by meeting both of the following criteria: - Wound closure - Scar quality (POSAS v2.0)	6 months post grafting	A composite endpoint whereby success is defined by meeting both of the following criteria: * Wound closure; * Scar quality (POSAS v2.0)

Secondary Outcome Measures

Name	Time	Method
Ratio of covered surface area to biopsy site/donor site surface area at 4 weeks post-grafting	4 weeks	Ratio of covered surface area to biopsy site/donor site surface area at 4 weeks post-grafting
Assessment of scar contracture	12 and 24 months post-grafting	Assessment of scar contracture
Epithelialisation percentage at 3 months and 6 months post-grafting	3 months and 6 months post-grafting	Epithelialisation percentage at 3 months and 6 months post-grafting
Graft take at 14 and 21 days post-grafting	14 and 21 days post-grafting	Graft take at 14 and 21 days post-grafting
Assessment of the donor sites	4 and 10 weeks, and 3, 6, 12, and 24 months post-grafting	Assessment of the donor sites
Assessment of the grafted burn wounds areas	4 and 10 weeks and 3, 6, 12, and 24 months post-grafting	Assessment of the grafted burn wounds areas

Trial Locations

Locations (1)

Rode Kruis Ziekenhuis; 🇳🇱 Beverwijk, Netherlands