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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Burn Injury, Soft Tissue Injury, Skin Necrosis, Scars, Congenital Giant Nevus, Skin Tumors

Intervention / Treatment
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* Biological: denovoDerm
* Biological: denovoSkin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Deep partial or full thickness skin defect of at least 9 cm2 requiring surgical wound coverage due to: Acute cases: burn injury, soft tissue injury, skin necrosis after purpura fulminans 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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: denovoDerm<br>Autologous tissue-engineered dermal substitute | Biological: denovoDerm<br>* Transplantation of an autologous tissue-engineered dermal substitute, covered with autologous split-thickness skin<br>|
| Experimental: denovoSkin<br>Autologous tissue-engineered dermo-epidermal skin substitute | Biological: denovoSkin<br>* Transplantation of autologous tissue-engineered dermo-epidermal skin substitute, no additional coverage needed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Assessment/reporting of local infection rate and graft take | denovoDerm: 4-6 days and 21 days after transplantation, denovoSkin 9-11 days and 21 days after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Assessment/reporting of number of adverse events | until 90 days post transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin, Tissue-engineering, Autologous, Dermis, Epidermis