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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02145130

Enrollment

Registered

2014-05-22

Start date

2014-05-31

Completion date

2021-03-31

Last updated

2021-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Skin, Tissue-engineering, Autologous, Dermis, Epidermis

Brief summary

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.

Interventions

BIOLOGICALdenovoDerm

Transplantation of an autologous tissue-engineered dermal substitute, covered with autologous split-thickness skin

BIOLOGICALdenovoSkin

Transplantation of autologous tissue-engineered dermo-epidermal skin substitute, no additional coverage needed

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Adverse events	until 90 days post transplantation	Assessment/reporting of number of adverse events

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026