Dimitropoulos G, Jafari P, de Buys Roessingh A, Hirt-Burri N, Raffoul W, Applegate L A
Plastic, Reconstructive & Hand Surgery, Unit of Regenerative Therapy, University Hospital of Lausanne, Switzerland.
Department of Pediatric Surgery, University Hospital of Lausanne, Switzerland.
Ann Burns Fire Disasters. 2016 Jun 30;29(2):111-115.
Application of cell therapies in burn care started in the early 80s in specialized hospital centers world-wide. Since 2007, cell therapies have been considered as "Advanced Therapy Medicinal Products" (ATMP), so classified by European Directives along with associated Regulations by the European Parliament. Consequently, regulatory changes have transformed the standard linear clinical care pathway into a more complex one. It is important to ensure the safety of cellular therapies used for burn patients and to standardize as much as possible the cell sources and products developed using cell culture procedures. However, we can definitely affirm that concentrating the bulk of energy and resources on the implementation of Good Manufacturing Practice (GMP) alone will have a major negative impact on the care of severely burned patients world-wide. Developing fully accredited infrastructures and training personnel (required by the new directives), along with obtaining approval for clinical trials to go ahead, can be a lengthy process.We discuss whether or not these patients could benefit from cell therapies provided by standard in-hospital laboratories, thus avoiding having to meet rigid regulations concerning the use of industrial pharmaceutical products. "Hospital Exemption" could be a preferred means to offer burn patients a customized and safe product, as many adaptations may be required throughout their treatment pathway. Patients who are in need of rapid treatment will be the ones to suffer the most from regulations intended to help them.
细胞疗法在烧伤护理中的应用始于80年代初，在全球范围内的专科医院中心开展。自2007年以来，细胞疗法被视为“先进治疗医药产品”（ATMP），这是根据欧洲指令以及欧洲议会的相关法规进行分类的。因此，监管变化将标准的线性临床护理路径转变为更为复杂的路径。确保用于烧伤患者的细胞疗法的安全性，并尽可能规范使用细胞培养程序开发的细胞来源和产品，这一点很重要。然而，我们可以肯定地说，仅将大量精力和资源集中在实施良好生产规范（GMP）上，将对全球严重烧伤患者的护理产生重大负面影响。建立完全认可的基础设施和培训人员（新指令所要求的），以及获得临床试验批准以推进，可能是一个漫长的过程。我们讨论这些患者是否可以从医院标准实验室提供的细胞疗法中受益，从而避免必须满足有关使用工业药品的严格规定。“医院豁免”可能是为烧伤患者提供定制化和安全产品的首选方式，因为在他们的整个治疗过程中可能需要进行许多调整。需要快速治疗的患者将是受旨在帮助他们的法规影响最大的人群。
