Clinical trial · Interventional
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
NCT02145130CI-TRIAL-00053749completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Burn Injury | — | UNRESOLVED | — |
| Congenital Giant Nevus | — | UNRESOLVED | — |
| Scars | — | UNRESOLVED | — |
| Skin Necrosis | — | UNRESOLVED | — |
| Skin Tumors | Skin Neoplasm | ALIAS | 0.90 |
| Soft Tissue Injury | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| denovoDerm | Biological | — | UNRESOLVED |
| denovoSkin | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- denovoDerm
- description
- Autologous tissue-engineered dermal substitute
- interventionNames
- Biological: denovoDerm
- type
- EXPERIMENTAL
- label
- denovoSkin
- description
- Autologous tissue-engineered dermo-epidermal skin substitute
- interventionNames
- Biological: denovoSkin
Primary outcomes (1)
- measure
- Safety
- timeFrame
- denovoDerm: 4-6 days and 21 days after transplantation, denovoSkin 9-11 days and 21 days after transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSchiestl C, Neuhaus K, Meuli M, Farkas M, Hartmann-Fritsch F, Elrod J, Bressan J, Reichmann E, Bottcher-Haberzeth S. Long-Term Outcomes of a Cultured Autologous Dermo-Epidermal Skin Substitute in Children: 5-Year Results of a Phase I Clinical Trial. J Burn Care Res. 2025 Mar 4;46(2):326-334. doi: 10.1093/jbcr/irae150. PMID 39115183