WP05: Phase 1 and 2 Clinical Trials

Objectives

The main objective of work package 05 (WP05) is the conduction of the Phase 1 and Phase 2 randomized Multi-Center Clinical Trials supported by Partner 01c (UZH-CTC) and in close collaboration with Partners 01a (UZH-TBRU), 02 (VUA) (including the Burn Center in Amsterdam) and Partner 03 (UKB, Unfallkranklenhaus Berlin) will develop the following objectives:

Objective 1: Ensure that the medical staffs of all 3 centers (UZH-UCH, VUA, UKB) are trained and familiar with the standard operating procedures and working instructions (SOPs, WIs) according to the study protocols.

Objective 2: Conduct the second and third arm of the Phase 1 studies, with patients with full thickness skin defects, grafted with either denovoDerm plus STS or denovoSkin.

Objective 3: Conduct and supervise (VUA and UKB) the Phase 2 randomized Multi-Center Clinical Trial.

Workpackage Description

In workpackage 5 the clinical research team of the pediatric burn center in Zurich will give support on implementing the clinical study protocol for Phase1 and Phase2 Clinical Trials.

Task 1: Study protocol

In close cooperation with clinical trial center of the university of Zurich we will finalize the study protocol (including SOPs, WIs) for the three-armed Phase 1 study as well as for the three-armed partially randomized Multi-Center-Clinical Trial.

Task 2: Training  

To ensure the accurate implementation of the study protocol, the 3 clinical teams of Zurich, Berlin and Amsterdam have to agree on a unified study protocol of surgical procedure. In cooperation with the clinical trial center of the university of Zurich a training program for clinical stuff members involved in the treatment of the selected patients in all three centers will be performed.

Task 3: Phase 1 study

Based on a close 10 year cooperation with Tissue biology research unit of the university children's hospital in Zurich and in order to have a door to door situation for the Phase 1 study of the more complex substitutes, we will conduct this part of the study only in Zurich. According to the study protocol, this two arms (denovoDerm and denovoSkin) of the three-armed Phase 1 study will be performed in our center.

Phase 1 clinical trials using NovoMaix in combination with split thickness skin will be undertaken by our partners in Amsterdam and Berlin respectively.

Task 4: Phase 2 multi-center clinical trial

Following the Phase 1 study and according to the study protocol, the three-armed randomized Phase 2, Multi-Center Clincal Trial, including 120-150 patients, will be performed together with the clinical centers in Amsterdam (Partner 02 VUA) and Berlin (Partner 03 UKB).