Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children

Inclusion Criteria:

• Age: <12 years of age

• Deep partial thickness and/or full-thickness burns requiring surgical wound coverage

• Expected that ≥90 cm2 of wound (not counting the head and neck area for studypatients in The Netherlands) will remain open at 4 weeks post burn despiteproceeding with treatment in accordance with the standard of care. >20% TBSA burnscan be taken as guideline, but TBSA is not an inclusion criterion.

• Signed Informed consent

Exclusion Criteria:

• Patients tested positive for HBV, HCV, syphilis or HIV

• Patients with known underlying or concomitant medical conditions that may interferewith normal wound healing (e.g. systemic skin and connective tissue diseases, anykind of congenital defect of metabolism including insulin-dependent diabetesmellitus, Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital oracquired immunosuppressive condition, chronic renal failure, or chronic hepaticdysfunction (Child-Pugh class B or C), severe malnutrition, or other concomitantillness which, in the opinion of the Investigator, has the potential tosignificantly delay wound healing)

• Severe drug and alcohol abuse

• Patients with a known history of malignancy

• Pre-existing coagulation disorders as defined by INR outside its normal value, PTT >ULN and fibrinogen <LLN prior to the current hospital admission and / or at theInvestigator's discretion

• Patients with known allergies to amphotericin B, gentamicin, penicillin,streptomycin, or bovine collagen

• Previous enrolment of the patient into the current phase II study

• Participation of the patient in another study with conflicting endpoints within 30days preceding and during the present study

• Patients or parents/legal guardian expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severepsychiatric disorders)

• Pregnant or breast feeding females

• Suspicion of child abuse

• Wounds in the head and neck area as study target area (only applicable for studypatients in The Netherlands)

• Enrolment of the Investigator, his/her family members, employees and other dependentpersons