Study on the first application of two skin replacement products made from the body's own cells for the treatment of large skin defects in children and adults
Summary description of the study
Extensive, deep skin injuries, such as those occurring in burns, still pose a significant clinical problem. An autologous skin replacement made of epidermis and dermis (autologous, dermo-epidermal) could be the optimal solution for addressing such skin defects. The TBRU (Tissue Biology Research Unit) has been producing skin replacement products using tissue engineering methods since 2001 and has successfully tested them in small and large animal models. Two novel types of skin replacements (denovoDerm and denovoSkin) have been developed. These graft products are intended to combine the structural and functional properties of healthy human skin to the greatest extent possible and will be used in the future for reconstructive and plastic surgical procedures. Both products are made from a small skin biopsy of the patient. In this phase I clinical study, the safety of denovoDerm and denovoSkin in patients with skin defects will be investigated. These skin replacement products will be transplanted in sizes ranging from 9 to 49 cm2. Remaining affected skin areas will be treated according to the current standard method with split-thickness skin grafts.
(BASEC)
Intervention under investigation
The graft products made from the body's own cells will be used as skin replacements approximately 2 to 5 weeks after biopsy collection. If the skin injury is larger than the manufactured products, the remaining skin injuries will be treated with standard therapy using split-thickness skin grafts. The graft products have a size of 45 +/- 4 cm2. The duration and execution of the transplantation, the associated hospital stay, and the course of the follow-up visits essentially correspond to routine surgery.
(BASEC)
Disease under investigation
Extensive skin injuries due to e.g. burns, scalds, scar corrections, large moles, or skin tumors.
(BASEC)
• Age: 1 to 70 years • Extensive second-degree, deep, and third-degree skin defects of at least 9 cm2 requiring surgical coverage of skin defects: a) Acute cases: e.g. due to burns or soft tissue injuries b) Reconstructive cases (elective surgeries): scarring after burns, congenital large moles • Written consent of patients/parents or legal representatives (BASEC)
Exclusion criteria
• Infected wounds or microbiological nasal swabs tested positive for multidrug-resistant germs • Patients with positive HBV, HCV, syphilis, or HIV tests • Patients with known underlying or comorbid conditions that may negatively affect normal wound healing (e.g. immunodeficiency, systemic skin diseases, all types of congenital metabolic diseases, including diabetes) • Coagulation disorders, defined as INR outside the normal range, PTT > normal range, and fibrinogen < normal range and/or at the physician's discretion • Previous inclusion in this study • Simultaneous participation in another study or participation in another study within 30 days prior to inclusion in this study • Expected non-compliance with the protocol by patients/parents/legal representatives • Suspected child abuse • Pregnant or breastfeeding women • Children with an allergy to gentamicin or amphotericin (BASEC)
Trial sites
Zurich
(BASEC)
Sponsor
not available
Contact
Contact Person Switzerland
Sophie Böttcher
+41 44 249 49 49
sophie.boettcher@clutterkispi.uzh.chUniversitätskinderspital Zürich
(BASEC)
General Information
University Children's Hospital, Zurich
+41 44 249 49 49
sophie.boettcher@clutterkispi.uzh.ch(ICTRP)
Scientific Information
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
29.01.2013
(BASEC)
ICTRP Trial ID
NCT02145130 (ICTRP)
Official title (approved by ethics committee)
not available
Academic title
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 (ICTRP)
Public title
Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin Defects (ICTRP)
Disease under investigation
Burn Injury;Soft Tissue Injury;Skin Necrosis;Scars;Congenital Giant Nevus;Skin Tumors (ICTRP)
Intervention under investigation
Biological: denovoDerm;Biological: denovoSkin (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
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
- 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
(ICTRP)
not available
Primary and secondary end points
Safety (ICTRP)
Adverse events (ICTRP)
Registration date
20.05.2014 (ICTRP)
Incorporation of the first participant
01.05.2014 (ICTRP)
Secondary sponsors
Clinical Trials Center Zurich (ICTRP)
Additional contacts
Sophie Sophie Böttcher, Prof. Dr. med., sophie.boettcher@kispi.uzh.ch, +41 44 249 49 49, University Children's Hospital, Zurich (ICTRP)
Secondary trial IDs
EuroSkinGraft / ESG-01-2011 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/show/NCT02145130 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available