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
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
• 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)
Studienstandort
Zürich
(BASEC)
Sponsor
nicht verfügbar
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Sophie Böttcher
+41 44 249 49 49
sophie.boettcher@clutterkispi.uzh.chUniversitätskinderspital Zürich
(BASEC)
Allgemeine Auskünfte
University Children's Hospital, Zurich
+41 44 249 49 49
sophie.boettcher@clutterkispi.uzh.ch(ICTRP)
Wissenschaftliche Auskünfte
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
29.01.2013
(BASEC)
ICTRP Studien-ID
NCT02145130 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
nicht verfügbar
Wissenschaftlicher Titel
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)
Öffentlicher Titel
Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin Defects (ICTRP)
Untersuchte Krankheit(en)
Burn Injury;Soft Tissue Injury;Skin Necrosis;Scars;Congenital Giant Nevus;Skin Tumors (ICTRP)
Untersuchte Intervention
Biological: denovoDerm;Biological: denovoSkin (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
Safety (ICTRP)
Adverse events (ICTRP)
Registrierungsdatum
20.05.2014 (ICTRP)
Einschluss des ersten Teilnehmers
01.05.2014 (ICTRP)
Sekundäre Sponsoren
Clinical Trials Center Zurich (ICTRP)
Weitere Kontakte
Sophie Sophie Böttcher, Prof. Dr. med., sophie.boettcher@kispi.uzh.ch, +41 44 249 49 49, University Children's Hospital, Zurich (ICTRP)
Sekundäre IDs
EuroSkinGraft / ESG-01-2011 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/show/NCT02145130 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar