NCT02145130

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2014

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

6.8 years

First QC Date

May 20, 2014

Last Update Submit

September 6, 2021

Conditions

Burn InjurySoft Tissue InjurySkin NecrosisScarsCongenital Giant NevusSkin Tumors

Keywords

SkinTissue-engineeringAutologousDermisEpidermis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Adverse events

    until 90 days post transplantation

Study Arms (2)

denovoDerm

EXPERIMENTAL

Autologous tissue-engineered dermal substitute

Biological: denovoDerm

denovoSkin

EXPERIMENTAL

Autologous tissue-engineered dermo-epidermal skin substitute

Biological: denovoSkin

Interventions

denovoDermBIOLOGICAL

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

denovoDerm
denovoSkinBIOLOGICAL

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

denovoSkin

Eligibility Criteria

Age1 Year - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Children's Hospital Zurich: denovoDerm

Zurich, Canton of Zurich, 8032, Switzerland

Location

University Children's Hospital Zurich: denovoSkin

Zurich, Canton of Zurich, 8032, Switzerland

Location

Related Publications (1)

  • Schiestl 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: 39115183DERIVED

MeSH Terms

Conditions

BurnsSoft Tissue InjuriesNecrosisCicatrixSkin Neoplasms

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathologic ProcessesPathological Conditions, Signs and SymptomsFibrosisNeoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sophie Böttcher, PD Dr. med.

    University Children's Hospital, Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 22, 2014

Study Start

May 1, 2014

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

September 8, 2021

Record last verified: 2021-09

Locations

CH(2)