Clinical trial NCT06745557: Phase III Study with an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Burns
Keywords: Burns
Skin
Scars
Wound healing
Dermis
Epidermis
Thermal burns
Lead sponsor: CUTISS AG
Sponsor class: INDUSTRY
Collaborators: name: RCTs
First posted: 2024-12-20
Enrollment: 70
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Intra-patient randomisation
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: A composite endpoint whereby success is defined by meeting both of the following criteria: - Wound closure - Scar quality (POSAS v2.0)
timeFrame: 6 months post grafting
Secondary outcomes:
measure: Ratio of covered surface area to biopsy site/donor site surface area at 4 weeks post-grafting
timeFrame: 4 weeks
measure: Assessment of scar contracture
timeFrame: 6 months post grafting
measure: Epithelialisation percentage at 3 months and 6 months post-grafting
timeFrame: 3 months and 6 months post-grafting
measure: Graft take at 14 and 21 days post-grafting
timeFrame: 14 and 21 days post-grafting
measure: Assessment of the donor sites
timeFrame: 4 and 10 weeks, and 3, 6, 12, and 24 months post-grafting
measure: Assessment of the grafted burn wounds areas
timeFrame: 4 and 10 weeks and 3, 6, 12, and 24 months post-grafting
measure: Assessment of scar contracture
timeFrame: 12 and 24 months post-grafting
Other outcomes:
measure: Assessment of safety and tolerability using the National Cancer Institute-CTCAE v5.0 throughout the study: - Assessment of the incidence of treatment-emergent adverse events (TEAEs), total AEs, and serious adverse events (SAEs)
timeFrame: 24 months
Locations:
city: Beverwijk
country: Netherlands
facility: Rode Kruis Ziekenhuis
Study officials:
References: