Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin Defects

A Phase I, Two Armed, Open, Prospective and Multicentre Study to Evaluate the Safety of Autologous Tissue-engineered Dermal Substitutes and Dermo-epidermal Skin Substitutes for the Treatment of Large Deep Partial and Full Thickness Skin Defects in Children and Adults

The purpose of this study is the evaluation of the safety of autologous tissue-engineered dermal substitutes "denovoDerm" (first arm) and dermo-epidermal skin substitutes "denovoSkin" (second arm) transplanted onto the wound bed in children and adults.

Inclusion Criteria:

• Deep partial or full thickness skin defect of at least 9 cm2 requiring surgical wound coverage due to:

  1. Acute cases: burn injury, soft tissue injury, skin necrosis after purpura fulminans
  2. Reconstructive cases (elective surgery): scar formation after burn injuries, congenital giant nevus, skin tumours

• Informed consent by patients/parents or other legal representatives

Exclusion Criteria:

• Infected wounds or positive general microbiological swabs taken from the nose for multi-resistant germs
• Patients tested positive for HBV, HCV, syphilis or HIV
• Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, systemic skin diseases, any kind of congenital defect of metabolism including diabetes)
• Coagulation disorders as defined by INR outside its normal value, PTT >ULN and fibrinogen <LLN and / or at the Investigator's discretion
• Previous enrolment of the patient into the current study
• Participation of the patient in another study within 30 days preceding and during the present study
• Patients or parents/other legal representatives expected not to comply with the study protocol
• Suspicion of child abuse
• Pregnant or breast feeding females
• Contamination derived from biopsy which could interfere with patients health
• Due to patient derived variations, isolated cells from biopsy do not proliferate or proliferate insufficiently
• Skin substitute has not been released due to production specific deviations
• Patients allergic to amphotericin B and gentamicin