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A prospective, multicentric, intrapatient-randomized, controlled, interventional Phase I clinical study applying novel bio-engineered pigmented and pre-vascularized autologous skin grafts (ATMPs) on severe skin lesions of both children and adults

English title A prospective, multicentric, intrapatient-randomized, controlled, interventional Phase I clinical study applying novel bio-engineered pigmented and pre-vascularized autologous skin grafts (ATMPs) on severe skin lesions of both children and adults
Applicant Schiestl Clemens
Number 180418
Funding scheme Investigator Initiated Clinical Trials (IICT)
Research institution Universitäts-Kinderspital Zürich
Institution of higher education University of Zurich - ZH
Main discipline Surgery
Start/End 01.12.2018 - 30.11.2023
Approved amount 2'123'255.00
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Keywords (4)

Skingraft; Bioengineering; Pigmented; Prevascularized

Lay Summary (German)

Lead
Wir testen klinisch, weltweit zum ersten Mal, eine personalisierte Ersatzhaut, die sowohl vorgefertigte Blutkapillaren als auch Pigmentzellen enthält. Das Kapillarnetz ermöglicht ein schnelles Anwachsen des Transplantats. Die Pigmentzellen stellen einen UV-Schutz und die passende Hautfarbe sicher.
Lay summary

Klinische Bedeutung der Therapie

Ausgedehnte und tiefe Hautdefekte (u.a. Verbrennungen) stellen immer noch ein grosses Behandlungsproblem dar. Die Resultate sind oft unbefriedigend. Der Hauptgrund dafür sind regelmässig grossflächigen Vernarbungen. Sie führen zu Bewegungseinschränkungen und wirken entstellend. Daher sind vor allem bei Kindern, häufig Korrekturoperationen notwendig. Diese zu verhindern und eine nahezu normale Haut herzustellen, mit funktionell und ästhetisch sehr guten Eigenschaften, ist unser therapeutisches Ziel.

 

Zu testende Intervention

In einem gemeinsamen Forschungsprojekt des Universitäts-Kinderspitals (Tissue Biology Research Unit und Zentrum für brandverletzte Kinder, Plastische u. Rekonstruktive Chirurgie) und des Universitätsspitals Zürich (Klinik für Plastische Chirurgie u. Handchirurgie), soll erstmals weltweit die von der TBRU entwickelte, autologe (aus den Zellen des Patienten bestehende) Ersatzhaut mit der herkömmlichen, heutigen Hautersatz-Methode (Eigenhautverpflanzung) verglichen werden. Dafür sollen am Kinderspital Zürich 10 Kinder und am Universitätsspital Zürich 10 Erwachsene in eine Studie eingeschlossen werden.

 

Erhoffter Effekt der Behandlung

Ziel dieser klinischen Studie ist es, nachzuweisen, dass die innovative Ersatzhaut aus dem Labor sicher und schnell einwächst (lebensrettend) und funktionell, als auch ästhetisch lebenslang, höchsten Ansprüchen genügt (Lebensqualität). Die heute üblichen, zahlreichen Narbenkorrekturen sollen entfallen, was einem bahnbrechenden Behandlungsfortschritt gleichkäme.

 


Direct link to Lay Summary Last update: 05.06.2018

Responsible applicant and co-applicants

Employees

Project partner

Scientific events

Active participation

Title Type of contribution Title of article or contribution Date Place Persons involved
Zurich Skin Symposium Talk given at a conference Introducing blood and colour (Thomas Biedermann), B2B – back and forth in clinical skin engineering (Jan Plock) & Challenges in translational research (Rocio Valencia) 05.11.2019 Universitäts Kinderspital Zürich, Switzerland Biedermann Thomas; Plock Jan;
18th European Burns Association Congress Talk given at a conference Engineering the Future-Skingineering (Martin Meuli), Bio-engineering human skin: the long way from basic research to clinical trials (Ernst Reichmann), Tissue engineering - Current State and Future Potential (Jan Plock) 04.09.2019 The Marina Congress Center, Helsinki, Finland Plock Jan;
HARTMANN Wundsymposium Talk given at a conference HARTMANN Wundsymposium 27.06.2019 Zürich, Switzerland Schiestl Clemens;


Self-organised

Title Date Place
Zurich Skin Symposium 05.12.2019 Universitäts Kinderspital Zürich, Switzerland

Communication with the public

Communication Title Media Place Year
Talks/events/exhibitions Scientifica 2021 German-speaking Switzerland 2021

Associated projects

Number Title Start Funding scheme
205706 Optical trapping and Raman spectroscopy combining BioRam for single cell and tissue analysis 01.01.2022 R'EQUIP

Abstract

The here-described PV-Skin-Project (P=Pigmented, V=Vascularized) is the result of 16 years of research. The study focuses on the clinical application of a novel Advanced Therapy Medicinal Product (ATMP) used to treat a broad spectrum of severe skin defects. The study is not in the focus of any industry, however, it certainly is of high clinical and social relevance. PV-Skin is the most advanced version of bio-engineered, autologous and permanent skin grafts the Tissue Biology Research Unit (TBRU) of the Department of Paediatric Surgery at the University Children’s Hospital in Zurich, has developed so far. PV-Skin is the next generation development of denovoSkin. DenovoSkin was also developed by the TBRU and was successfully applied in Phase I clinical trials on 10 pediatric patients in Zurich (manuscript submitted). First clinical results with denovoSkin are extremely promising. An Independent Data Safety Monitoring Board has qualified denovoSkin as safe. Phase II studies have now (December 2017) commenced in both at the University Children’s Hospital (treating children) and the University Hospital (treating adults) in Zurich. The denovoSkin clinical project was initially reviewed by several instances and was awarded significant financial support under highly competitive conditions (by the FP7 program - resulting in EuroSkinGraft, by the Mme Curie Mobility Program, by the Clinical Research Priority Program (CRPP) of the University of Zurich), so that Phase I clinical trials could be financed and undertaken by a consortium of academic institutions. Although to date denovoSkin is (wordwide) one of the most advanced (perhaps the most advanced) autologous bio-engineered skin graft applied in the clinic, it is neither pigmented nor does it contain a capillary plexus. Notably, just these two most important properties (pigmentation and pre-vascularization) can now routinely be bio-engineered into denovoSkin by the TBRU, which results in the generation of PV-Skin. We have shown that the pre-existing functional capillary plexus (established in PV-Skin) triggers the rapid connection (inosculation) of this plexus to capillaries of the underlying wound bed within only 4 days after transplantation (Klar et al., 2014). This rapid inosculation significantly speeds up take, wound healing, resistance to infection, and skin tissue homeostasis (Klar et al, 2014 and Marino et al., 2014). The method of pre-pigmenting PV-Skin is expected to guarantee a matching skin color and the protection of epidermal keratinocytes from the harmful effects of UV irradiation.
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