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

• Register: ClinicalTrials.gov
• Last refreshed on: 20 September 2021
• Main ID: NCT02145130
• Date of registration: 20/05/2014
• Prospective Registration: No
• Primary sponsor: University of Zurich
• Public title: Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin Defects
• Scientific 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
• Date of first enrolment: May 2014
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02145130
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Netherlands, Switzerland

Contacts

• Name: Sophie Böttcher, PD Dr. med.
• Affiliation: University Children's Hospital, Zurich

Key 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



Age minimum: 1 Year
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Skin Necrosis

Burn Injury

Congenital Giant Nevus

Soft Tissue Injury

Scars

Skin Tumors

Intervention(s)

Biological: denovoDerm

Biological: denovoSkin

Primary Outcome(s)

Safety [Time Frame: denovoDerm: 4-6 days and 21 days after transplantation, denovoSkin 9-11 days and 21 days after transplantation]

Secondary Outcome(s)

Adverse events [Time Frame: until 90 days post transplantation]

Secondary ID(s)

EuroSkinGraft / ESG-01-2011

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital, Zürich