Maintaining therapeutic activity in the operating room: compatibility of a gamma-retroviral replicating vector with clinical materials and biofluids.
Maintaining therapeutic activity in the operating room: compatibility of a gamma-retroviral replicating vector with clinical materials and biofluids.
复制标题
在手术室中维持治疗活性：γ-逆转录病毒复制载体与临床材料和生物液体的相容性。
DOI：
10.1038/mtm.2014.24
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发表时间：
2014
期刊：
影响因子：
--
通讯作者：
Jolly,DouglasJ
中科院分区：
文献类型：
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作者：
Burnett,Ryan;Ibañez,CarlosE;Pettersson,PärL;Chen,Ching-I;Parab,Shraddha;Huang,Tiffany;Robbins,Joan;Bankiewicz,Krystof;Aghi,Manish;Logg,Christopher;Kasahara,Noriyuki;Pertschuk,Dan;Gruber,HarryE;Jolly,DouglasJ
Toca 511是一种新型逆转录病毒复制载体，编码一种修饰的酵母胞嘧啶脱氨酶，在I期试验中通过立体定向经颅注射至肿瘤或切除腔壁，对复发性高级别胶质瘤患者进行给药。一个关键的问题，几乎没有发表的数据，是载体的生物相容性与代理可能会遇到在神经外科设置。我们测试了Toca 511与以下器械的生物相容性：输送器械; MRI造影剂，包括支持真实的时间MRI引导肿瘤内输送的ProHance共注射;止血剂;生物液体（血液和脑脊液）;潜在佐剂;以及可降低意外针刺风险的无针小瓶适配器。Toca 511在环境温度下解冻后可稳定至少6小时，为给药提供足够的时间，并且在存在以下物质的情况下其活力不会降低：不锈钢和二氧化硅基输送装置;潜在的MRI造影剂Feraheme;多种浓度的ProHance;止血剂STERIFOAM;血液;脑脊液;和无针小瓶适配器。Toca 511与止血剂SURGICEL或长期暴露于钛基活检针不相容。
Toca 511 is a novel retroviral replicating vector, encoding a modified yeast cytosine deaminase, administered to recurrent high grade glioma patients in Phase 1 trials by stereotactic, transcranial injection into the tumor or into the walls of the resection cavity. A key issue, with little published data, is vector biocompatibility with agents likely to be encountered in a neurosurgical setting. We tested biocompatibility of Toca 511 with: delivery devices; MRI contrast agents, including ProHance supporting coinjection for real time MRI-guided intratumoral delivery; hemostatic agents; biofluids (blood and cerebrospinal fluid); potential adjuvants; and a needleless vial adapter that reduces risk of accidental needle sticks. Toca 511 is stable upon thawing at ambient temperature for at least 6 hours, allowing sufficient time for administration, and its viability is not reduced in the presence of: stainless steel and silica-based delivery devices; the potential MRI contrast agent, Feraheme; ProHance at several concentrations; the hemostatic agent SURGIFOAM; blood; cerebrospinal fluid; and the needleless vial adapter. Toca 511 is not compatible with the hemostatic agent SURGICEL or with extended exposures to titanium-based biopsy needles.