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

Launched by CUTISS AG · Dec 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called denovoSkin™ for adults and adolescents aged 12 and older who have severe burns that cover a significant part of their body. The goal is to see if denovoSkin™ can help heal burn wounds faster and with less scarring compared to the standard treatment, which involves using a type of skin graft called split-thickness skin grafts (STSG). The study is currently looking for participants, and it’s taking place at multiple locations.

To be eligible for this trial, participants need to have deep burns that affect at least 20% of their body. They should be at least 12 years old and able to provide consent, or have a guardian who can consent for them. However, this study excludes individuals with burns only on their head or neck, those who can be treated with a single surgery without delay, and patients with certain medical conditions that could hinder healing. If someone decides to join the trial, they can expect to receive either the new treatment or the standard care, and they will be monitored closely throughout the process to assess how well the treatment works.

Gender

ALL

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