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cured hepatitis C (defined as documented treatment and negative viral load) is not an exclusion\n* 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\u002Fmol and\u002For systemic skin and connective tissue diseases\n* 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\n* Patients with a history of clinically significant hypersensitivity to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen and it's derivatives (e.g. gelatine)\n* Previous treatment with denovoSkin™\n* Participation in any clinical interventional study within 60 days prior to the first IMP administration in case of monoclonal antibodies and \\\u003C30 days for all other IMPs\n* Patients unwilling or unable to comply with procedures required in this clinical study protocol\n* Pregnant or lactating women\n* Women of child-bearing potential not using highly effective method(s) of birth control (i.e., with low failure rate \\\u003C1% per year) throughout the study and\u002For unwilling to be tested for pregnancy. A negative serum beta-human chorionic gonadotropin (β-hCG) test is required on the day of grafting\n* Patient is the Investigator, one of his\u002Fher family members, employees, and other dependent persons","ALL","12 Years",{"count":340,"type":341},70,"ESTIMATED","INTERVENTIONAL",[344],"PHASE3","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.",[347],"Burns",[347,349,350,351,352,353,354],"Skin","Scars","Wound healing","Dermis","Epidermis","Thermal burns","2026-08-06",{"date":357,"type":358},"2026-08-10","ACTUAL",{"date":360,"type":358},"2024-12-13",{"date":362,"type":341},"2029-06-30",{"name":5,"class":6},19]