Processing laboratory considerations for multi-center cellular therapy clinical trials: a report from the Consortium for Pediatric Cellular Immunotherapy.
Processing laboratory considerations for multi-center cellular therapy clinical trials: a report from the Consortium for Pediatric Cellular Immunotherapy.
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多中心细胞疗法临床试验的加工实验室注意事项：小儿细胞免疫疗法财团的报告。
DOI：
10.1016/j.jcyt.2020.09.013
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发表时间：
2021-03
期刊：
影响因子：
4.5
通讯作者：
Hanley PJ
中科院分区：
文献类型：
--
作者：
Lindgren C;Leinbach A;Annis J;Tanna J;Zhang N;Esensten JH;Hanley PJ
细胞疗法最初是作为专门疗法出现的，只在世界范围内的几个“精品”中心提供。为了确保广泛获得这些研究疗法--无论地理、人口统计学和其他因素--越来越多的学术临床试验正在变得多中心。这样的试验通常是由一个中央制造设施接收起始材料，并将新鲜或冷冻保存的最终产品运送到患者的机构进行输液。随着这些学术多中心试验数量的增加，至关重要的是制定程序和培训计划，使这些远离生产设施的地点能够成功参与这些试验，并满足法规遵从性和患者安全最佳实践。根据儿科细胞免疫治疗联盟的集体经验，我们总结了各机构在运送和接收起始材料和最终产品以及准备最终产品用于输液时遇到的挑战。我们还讨论了每个联合体机构为克服这些挑战而实施的最佳做法。
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, we summarize the challenges encountered by the institutions in shipping and receiving the starting material and final product as well as preparing the final product for infusion. We also discuss best practices implemented by each of the consortia institutions to overcome these challenges.
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影响因子：
2.9
作者：
Chen, Leonard N.;Collins-Johnson, Naoza;Panch, Sandhya R.
通讯作者：
Panch, Sandhya R.
DOI：
10.1056/nejmoa1103849
发表时间：
2011-08-25
期刊：
The New England journal of medicine
影响因子：
--
作者：
Porter DL;Levine BL;Kalos M;Bagg A;June CH
通讯作者：
June CH
DOI：
10.1016/j.omtm.2016.12.006
发表时间：
2017-03-17
期刊：
Molecular therapy. Methods & clinical development
影响因子：
--
作者：
Levine BL;Miskin J;Wonnacott K;Keir C
通讯作者：
Keir C
DOI：
10.1056/nejmoa1215134
发表时间：
2013-04-18
期刊：
The New England journal of medicine
影响因子：
--
作者：
Grupp SA;Kalos M;Barrett D;Aplenc R;Porter DL;Rheingold SR;Teachey DT;Chew A;Hauck B;Wright JF;Milone MC;Levine BL;June CH
通讯作者：
June CH