WHO ICTRP trial

A study to check if the use of a skin model engeneered in the laboratory by…

EUCTR2017-002462-41-IT · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2017-002462-41-IT
Public title A study to check if the use of a skin model engeneered in the laboratory by using your own skin cells (EHSG-KF), is safe and effective to treat partial deep dermal and full thickness skin defects in adults and children in comparison to autologous split-thickness skin grafts (STSG)
Scientific title A Phase II, prospective, intra-patient randomized controlled, multicentre study to evaluate the safety and efficacy of an autologous bio-engineered dermo-epidermal skin substitute (EHSG-KF) for the treatment of full thickness skin defects in adults and children in comparison to autologous…
Primary sponsor University of Zurich, Tissue Biology Research Unit
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Netherlands;Italy;Switzerland
Conditions Adults and children with full thickness skin defects.;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Interventions Product Name: EHSG-KF Product Code: EHSG-KF Pharmaceutical Form: Cutaneous patch INN or Proposed INN: Autogolous Skin Cells CAS Number: na Current Sponsor code: na Other descriptive name: Human Autologous Skin Cells Concentration unit…
Registration date Dec 13, 2019
Target size 20
Secondary IDs TBRU-dS-RAC-PII;2017-002462-41-NL
Registry page clinicaltrialsregister.eu

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