BetaGlue Technologies SpA, Milan, Italy;
King's College London, London, U.K.
In Vivo. 2022 Sep-Oct;36(5):2052-2060. doi: 10.21873/invivo.12931.
BACKGROUND/AIM: BAT-90 is an innovative active implantable device designed for the irradiation of unresectable tumors (e.g., liver cancer) or surgical tumor beds, based on the combination of Yttrium-90 beta-emitting microspheres and a tissue adhesive hydrogel, currently used in cardio-vascular surgery. The rationale behind BAT-90 is to localize the Yttrium-90 activity on the administration site, while minimizing its body dispersion.
The effective induction of necrosis in the target injection area was tested in a pig liver model, whereas the safety of BAT-90 was assessed and demonstrated in biocompatibility tests for acute systemic toxicity, intracutaneous reactivity, delayed hypersensitivity and subcutaneous implantation.
BAT-90 administration induced necrosis into the target site, while the safety experiments in the treated animals highlighted results very similar to the controls.
BAT-90 could be considered as a safe and innovative treatment option for inoperable solid tumors of the liver.
背景/目的:BAT-90 是一种创新的主动植入式设备,基于钇-90β发射微球和组织黏附水凝胶的组合,专为无法切除的肿瘤(如肝癌)或手术肿瘤床的照射而设计,目前用于心血管外科学。BAT-90 的基本原理是将钇-90 活性定位在给药部位,同时将其在体内的扩散降至最低。
在猪肝模型中测试了在目标注射区域有效诱导坏死的能力,而在急性全身毒性、皮内反应、迟发性过敏和皮下植入的生物相容性测试中评估和证明了 BAT-90 的安全性。
BAT-90 的给药导致目标部位发生坏死,而在治疗动物中的安全性实验结果与对照组非常相似。
BAT-90 可被视为一种安全且具创新性的治疗选择,适用于无法手术的肝脏实体瘤。