Laurent Alexis, Rey Marina, Scaletta Corinne, Abdel-Sayed Philippe, Michetti Murielle, Flahaut Marjorie, Raffoul Wassim, de Buys Roessingh Anthony, Hirt-Burri Nathalie, Applegate Lee Ann
Regenerative Therapy Unit, Lausanne University Hospital, University of Lausanne, CH-1066 Epalinges, Switzerland.
Manufacturing Department, TEC-PHARMA SA, CH-1038 Bercher, Switzerland.
Pharmaceutics. 2023 Jan 4;15(1):184. doi: 10.3390/pharmaceutics15010184.
Allogeneic dermal progenitor fibroblasts constitute cytotherapeutic contenders for modern cutaneous regenerative medicine. Based on advancements in the relevant scientific, technical, and regulatory fields, translational developments have slowly yet steadily led to the clinical application of such biologicals and derivatives. To set the appropriate general context, the first aim of this study was to provide a current global overview of approved cell and gene therapy products, with an emphasis on cytotherapies for cutaneous application. Notable advances were shown for North America, Europe, Iran, Japan, and Korea. Then, the second and main aim of this study was to perform a retrospective analysis on the various applications of dermal progenitor fibroblasts and derivatives, as clinically used under the Swiss progenitor cell transplantation program for the past three decades. Therein, the focus was set on the extent and versatility of use of the therapies under consideration, their safety parameters, as well as formulation options for topical application. Quantitative and illustrative data were summarized and reported for over 300 patients treated with various cell-based or cell-derived preparations (e.g., progenitor biological bandages or semi-solid emulsions) in Lausanne since 1992. Overall, this study shows the strong current interest in biological-based approaches to cutaneous regenerative medicine from a global developmental perspective, as well as the consolidated local clinical experience gathered with a specific and safe allogeneic cytotherapeutic approach. Taken together, these current and historical elements may serve as tangible working bases for the further optimization of local and modern translational pathways for the provision of topical cytotherapeutic care.
同种异体真皮祖细胞成纤维细胞是现代皮肤再生医学中细胞治疗的有力竞争者。基于相关科学、技术和监管领域的进展,转化研究缓慢但稳步地推动了这类生物制品及其衍生物的临床应用。为了奠定适当的总体背景,本研究的首要目标是提供当前全球获批的细胞和基因治疗产品的概述,重点是用于皮肤的细胞治疗。北美、欧洲、伊朗、日本和韩国都有显著进展。然后,本研究的第二个也是主要目标是对真皮祖细胞成纤维细胞及其衍生物的各种应用进行回顾性分析,这些应用是在过去三十年瑞士祖细胞移植项目的临床应用中使用的。其中,重点是所考虑疗法的使用范围和通用性、其安全参数以及局部应用的制剂选择。自1992年以来,对洛桑300多名接受各种基于细胞或细胞衍生制剂(如祖细胞生物绷带或半固体乳剂)治疗的患者的定量和说明性数据进行了总结和报告。总体而言,本研究从全球发展的角度展示了目前对基于生物的皮肤再生医学方法的浓厚兴趣,以及通过一种特定且安全的同种异体细胞治疗方法积累的巩固的当地临床经验。综上所述,这些当前和历史因素可为进一步优化提供局部细胞治疗护理的本地和现代转化途径提供切实可行的工作基础。