Lindgren Catherine, Leinbach Ashley, Annis Julie, Tanna Jay, Zhang Nan, Esensten Jonathan H, Hanley Patrick J
Seattle Children's Research Institute, Seattle, Washington, USA.
University of California San Francisco, San Francisco, California, USA.
Cytotherapy. 2021 Feb;23(2):157-164. doi: 10.1016/j.jcyt.2020.09.013. Epub 2020 Nov 12.
``Cellular therapies first emerged as specialized therapies only available at a few "boutique" centers worldwide. To ensure broad access to these investigational therapies-regardless of geography, demographics and other factors-more and more academic clinical trials are becoming multi-center. Such trials are typically performed with a centralized manufacturing facility receiving the starting material and shipping the final product, either fresh or cryopreserved, to the patient's institution for infusion. As these academic multi-center trials increase in number, it is critical to have procedures and training programs in place to allow these sites that are remote from the production facility to successfully participate in these trials and satisfy regulatory compliance and patient safety best practices. Based on the collective experience of the Consortium for Pediatric Cellular Immunotherapy, the authors summarize the challenges encountered by institutions in shipping and receiving the starting material and final product as well as preparing the final product for infusion. The authors also discuss best practices implemented by each of the consortia institutions to overcome these challenges.
细胞疗法最初作为一种特殊疗法，仅在全球少数“精品”中心提供。为确保无论地理、人口统计学和其他因素如何，都能广泛获得这些研究性疗法，越来越多的学术临床试验正在成为多中心试验。此类试验通常由一个集中的生产设施进行，该设施接收起始材料，并将新鲜或冷冻保存的最终产品运送到患者所在机构进行输注。随着这些学术多中心试验数量的增加，制定程序和培训计划至关重要，以便那些远离生产设施的地点能够成功参与这些试验，并满足法规要求和患者安全最佳实践。基于儿科细胞免疫治疗联盟的集体经验，作者总结了各机构在运输和接收起始材料及最终产品以及为输注准备最终产品时遇到的挑战。作者还讨论了各联盟机构为克服这些挑战而实施的最佳实践。
