Auxenfans Celine, Valencia Rocio G, Abdel-Sayed Philippe, Alaminos Miguel, Brunet Jean-François, Campos Fernando, Chato-Astrain Jesus, Carmona Gloria, de Buys Roessingh Anthony, Droz-Georget Stephanie, Farkas Melinda, Fernandez Gonzalez Ana, Gönczi Enikö, Huss Fredrik, Hartmann Bernd, Heusi Barbara, Karström Alexandra, Moiemen Naiem, Sartoris Giulia, Spranger Antje, Trouillas Marina, Rosas Claudia, Vuola Jyrki, Woodtli Vivienne, Schiestl Clemens, Böttcher Sophie
Banque de Tissus et Cellules, Plateforme de Biotherapies, Hospices Civils de Lyon, 69002 Lyon, France.
Pediatric Burn Center, Children's Skin Center, Department of Surgery, University Children's Hospital Zurich, University of Zurich, Lenggstrassse 30, 8008 Zurich, Switzerland.
Eur Burn J. 2025 Jun 3;6(2):30. doi: 10.3390/ebj6020030.
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.
自体皮肤替代物是烧伤治疗领域一项很有前景的进展，为大面积皮肤缺失的患者提供了个性化的解决方案。本白皮书综合了欧洲目前关于实验室制备的自体皮肤替代物的知识，纳入了专家意见和法律考量。白皮书探讨了自体皮肤替代物研发的科学原理，包括细胞来源、生物工程技术和临床应用。还考察了欧洲管理这些先进疗法生产和使用的监管框架，突出了标准化、安全性和审批途径方面的挑战。文本中有专家见解，提供了关于自体皮肤替代物临床可行性和转化障碍的现实视角。研究结果凸显了自体皮肤替代物改善烧伤治疗效果的潜力，同时强调需要统一的法规来促进临床应用。尽管有技术进步，但重大挑战依然存在，包括生产成本、可扩展性和长期疗效。本白皮书的另一个重点是法律变化，这些变化对这些技术的生产和可得性产生了重大影响。综述得出结论，虽然自体皮肤替代物前景广阔，但进一步的研究、监管完善和跨学科合作对于优化其临床实践整合至关重要。
