Laboratory-Generated Autologous Skin Substitutes for Burn Treatment in Europe: Narrative Review, Experts’ Opinion, and Legal Considerations
Autologous skin substitutes represent a promising advancement in the treatment of burn injuries, offering personalized solutions for patients with extensive skin loss. This white paper synthesizes the current knowledge on laboratory-generated autologous skin substitutes in Europe, incorporating expe...
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| Format: | Article |
| Language: | English |
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MDPI AG
2025-06-01
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| Series: | European Burn Journal |
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| Online Access: | https://www.mdpi.com/2673-1991/6/2/30 |
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| author | Celine Auxenfans Rocio G. Valencia Philippe Abdel-Sayed Miguel Alaminos Jean-François Brunet Fernando Campos Jesus Chato-Astrain Gloria Carmona Anthony de Buys Roessingh Stephanie Droz-Georget Melinda Farkas Ana Fernandez Gonzalez Enikö Gönczi Fredrik Huss Bernd Hartmann Barbara Heusi Alexandra Karström Naiem Moiemen Giulia Sartoris Antje Spranger Marina Trouillas Claudia Rosas Jyrki Vuola Vivienne Woodtli Clemens Schiestl Sophie Böttcher |
| author_facet | Celine Auxenfans Rocio G. Valencia Philippe Abdel-Sayed Miguel Alaminos Jean-François Brunet Fernando Campos Jesus Chato-Astrain Gloria Carmona Anthony de Buys Roessingh Stephanie Droz-Georget Melinda Farkas Ana Fernandez Gonzalez Enikö Gönczi Fredrik Huss Bernd Hartmann Barbara Heusi Alexandra Karström Naiem Moiemen Giulia Sartoris Antje Spranger Marina Trouillas Claudia Rosas Jyrki Vuola Vivienne Woodtli Clemens Schiestl Sophie Böttcher |
| author_sort | Celine Auxenfans |
| collection | DOAJ |
| description | Autologous skin substitutes represent a promising advancement in the treatment of burn injuries, offering personalized solutions for patients with extensive skin loss. This white paper synthesizes the current knowledge on laboratory-generated autologous skin substitutes in Europe, incorporating expert opinions and legal considerations. The white paper examines the scientific principles underlying autologous skin substitute development, including cell sourcing, bioengineering techniques, and clinical applications. The regulatory framework governing the production and use of these advanced therapies in Europe is also examined, highlighting challenges in standardization, safety, and approval pathways. The text features expert insights that offer a real-world perspective on the clinical viability and translational hurdles of autologous skin substitutes. The findings highlight the potential of autologous skin substitutes to improve burn treatment outcomes while emphasizing the need for harmonized regulations to facilitate clinical implementation. Despite technological advancements, significant challenges persist, including production costs, scalability, and long-term efficacy. Another focus of this white paper are the legal changes, which have significantly impacted the production and availability of these technologies. The review concludes that while autologous skin substitutes hold great promise, further research, regulatory refinement, and interdisciplinary collaboration are essential to optimize their integration into clinical practice. |
| format | Article |
| id | doaj-art-0c1551d5ed6a41e8912cc03d402203be |
| institution | OA Journals |
| issn | 2673-1991 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | European Burn Journal |
| spelling | doaj-art-0c1551d5ed6a41e8912cc03d402203be2025-08-20T02:24:21ZengMDPI AGEuropean Burn Journal2673-19912025-06-01623010.3390/ebj6020030Laboratory-Generated Autologous Skin Substitutes for Burn Treatment in Europe: Narrative Review, Experts’ Opinion, and Legal ConsiderationsCeline Auxenfans0Rocio G. Valencia1Philippe Abdel-Sayed2Miguel Alaminos3Jean-François Brunet4Fernando Campos5Jesus Chato-Astrain6Gloria Carmona7Anthony de Buys Roessingh8Stephanie Droz-Georget9Melinda Farkas10Ana Fernandez Gonzalez11Enikö Gönczi12Fredrik Huss13Bernd Hartmann14Barbara Heusi15Alexandra Karström16Naiem Moiemen17Giulia Sartoris18Antje Spranger19Marina Trouillas20Claudia Rosas21Jyrki Vuola22Vivienne Woodtli23Clemens Schiestl24Sophie Böttcher25Banque de Tissus et Cellules, Plateforme de Biotherapies, Hospices Civils de Lyon, 69002 Lyon, FrancePediatric Burn Center, Children’s Skin Center, Department of Surgery, University Children’s Hospital Zurich, University of Zurich, Lenggstrassse 30, 8008 Zurich, SwitzerlandRegenerative Therapy Unit, Service of Plastic, Reconstructive & Hand Surgery, Lausanne University Hospital, University of Lausanne, 1011 Lausanne, SwitzerlandTissue Engineering Group, Department of Histology, Instituto de Investigación Biosanitaria ibs.GRANADA, University of Granada, 18012 Granada, SpainCell Production Center (CPC), Lausanne University Hospital (CHUV), 1005 Lausanne, SwitzerlandTissue Engineering Group, Department of Histology, Instituto de Investigación Biosanitaria ibs.GRANADA, University of Granada, 18012 Granada, SpainTissue Engineering Group, Department of Histology, Instituto de Investigación Biosanitaria ibs.GRANADA, University of Granada, 18012 Granada, SpainAndalusian Network for the Design and Translation of Advanced Therapies (AND&TAT)—Fundación Pública Andaluza Progreso y Salud, 41092 Sevilla, SpainChildren and Adolescent Surgery Service, Lausanne University Hospital, University of Lausanne, 1015 Lausanne, SwitzerlandLaboratory of Stem Cell Dynamics, School of Life Sciences, École Polytechnique Fédérale de Lausanne, 1015 Lausanne, SwitzerlandPediatric Burn Center, Children’s Skin Center, Department of Surgery, University Children’s Hospital Zurich, University of Zurich, Lenggstrassse 30, 8008 Zurich, SwitzerlandAndalusian Network for the Design and Translation of Advanced Therapies (AND&TAT)—Fundación Pública Andaluza Progreso y Salud, 41092 Sevilla, SpainPediatric Burn Center, Children’s Skin Center, Department of Surgery, University Children’s Hospital Zurich, University of Zurich, Lenggstrassse 30, 8008 Zurich, SwitzerlandDepartment of Plastic and Maxillofacial Surgery, Department of Surgical Sciences, Uppsala University Hospital, 752 37 Uppsala, SwedenUnfallkrankenhaus Berlin, 12683 Berlin, GermanyPediatric Burn Center, Children’s Skin Center, Department of Surgery, University Children’s Hospital Zurich, University of Zurich, Lenggstrassse 30, 8008 Zurich, SwitzerlandDepartment of Plastic and Maxillofacial Surgery, Department of Surgical Sciences, Uppsala University Hospital, 752 37 Uppsala, SwedenCollege of Medicine and Health, University of Birmingham, Edgbaston, Birmingham B15 2TT, UKPediatric Burn Center, Children’s Skin Center, Department of Surgery, University Children’s Hospital Zurich, University of Zurich, Lenggstrassse 30, 8008 Zurich, SwitzerlandUnfallkrankenhaus Berlin, 12683 Berlin, GermanyATMP Unit, French Armed-Forces Blood Transfusion Center, 92140 Clamart, FrancePediatric Burn Center, Children’s Skin Center, Department of Surgery, University Children’s Hospital Zurich, University of Zurich, Lenggstrassse 30, 8008 Zurich, SwitzerlandHelsinki Burn Centre, Helsinki University Hospital, University of Helsinki, P.O. Box 263, 00029 Helsinki, FinlandPediatric Burn Center, Children’s Skin Center, Department of Surgery, University Children’s Hospital Zurich, University of Zurich, Lenggstrassse 30, 8008 Zurich, SwitzerlandPediatric Burn Center, Children’s Skin Center, Department of Surgery, University Children’s Hospital Zurich, University of Zurich, Lenggstrassse 30, 8008 Zurich, SwitzerlandPediatric Burn Center, Children’s Skin Center, Department of Surgery, University Children’s Hospital Zurich, University of Zurich, Lenggstrassse 30, 8008 Zurich, SwitzerlandAutologous skin substitutes represent a promising advancement in the treatment of burn injuries, offering personalized solutions for patients with extensive skin loss. This white paper synthesizes the current knowledge on laboratory-generated autologous skin substitutes in Europe, incorporating expert opinions and legal considerations. The white paper examines the scientific principles underlying autologous skin substitute development, including cell sourcing, bioengineering techniques, and clinical applications. The regulatory framework governing the production and use of these advanced therapies in Europe is also examined, highlighting challenges in standardization, safety, and approval pathways. The text features expert insights that offer a real-world perspective on the clinical viability and translational hurdles of autologous skin substitutes. The findings highlight the potential of autologous skin substitutes to improve burn treatment outcomes while emphasizing the need for harmonized regulations to facilitate clinical implementation. Despite technological advancements, significant challenges persist, including production costs, scalability, and long-term efficacy. Another focus of this white paper are the legal changes, which have significantly impacted the production and availability of these technologies. The review concludes that while autologous skin substitutes hold great promise, further research, regulatory refinement, and interdisciplinary collaboration are essential to optimize their integration into clinical practice.https://www.mdpi.com/2673-1991/6/2/30autologous skin substituteburn treatmentlegal considerations |
| spellingShingle | Celine Auxenfans Rocio G. Valencia Philippe Abdel-Sayed Miguel Alaminos Jean-François Brunet Fernando Campos Jesus Chato-Astrain Gloria Carmona Anthony de Buys Roessingh Stephanie Droz-Georget Melinda Farkas Ana Fernandez Gonzalez Enikö Gönczi Fredrik Huss Bernd Hartmann Barbara Heusi Alexandra Karström Naiem Moiemen Giulia Sartoris Antje Spranger Marina Trouillas Claudia Rosas Jyrki Vuola Vivienne Woodtli Clemens Schiestl Sophie Böttcher Laboratory-Generated Autologous Skin Substitutes for Burn Treatment in Europe: Narrative Review, Experts’ Opinion, and Legal Considerations European Burn Journal autologous skin substitute burn treatment legal considerations |
| title | Laboratory-Generated Autologous Skin Substitutes for Burn Treatment in Europe: Narrative Review, Experts’ Opinion, and Legal Considerations |
| title_full | Laboratory-Generated Autologous Skin Substitutes for Burn Treatment in Europe: Narrative Review, Experts’ Opinion, and Legal Considerations |
| title_fullStr | Laboratory-Generated Autologous Skin Substitutes for Burn Treatment in Europe: Narrative Review, Experts’ Opinion, and Legal Considerations |
| title_full_unstemmed | Laboratory-Generated Autologous Skin Substitutes for Burn Treatment in Europe: Narrative Review, Experts’ Opinion, and Legal Considerations |
| title_short | Laboratory-Generated Autologous Skin Substitutes for Burn Treatment in Europe: Narrative Review, Experts’ Opinion, and Legal Considerations |
| title_sort | laboratory generated autologous skin substitutes for burn treatment in europe narrative review experts opinion and legal considerations |
| topic | autologous skin substitute burn treatment legal considerations |
| url | https://www.mdpi.com/2673-1991/6/2/30 |
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