RE. Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology, NAS of Ukraine, Kyiv, Ukraine.
BMC Pharmacol Toxicol. 2022 Jun 8;23(1):37. doi: 10.1186/s40360-022-00577-3.
The assessment of biosafety of pharmacologically active substances is crucial for determining the feasibility of their medical use. There are controversial issues regarding the use of substances of different origins as implants.
We have conducted the comprehensive studies to determine the in vivo toxicity and in vitro genotoxicity of new generation of hydrophilic gel for implantation (production name of the substance "Activegel") to detail its characteristics and assess its biosafety.
In vivo studies have shown the absence of clinical manifestations of intoxication in animals and no abnormalities in their physiological condition, general and biochemical blood tests. Evaluation of the site of the gel application showed no inflammatory reaction and evidenced on normal state of tissues of animal skin. The results of the genotoxicity test indicated that the gel did not affect the parameters of DNA comets and the formation of micronuclei, accordingly, had no genotoxic effect on human peripheral blood lymphocytes. When studying the effect of the gel on malignantly transformed cells in vitro, it was found that the gel for implantation did not change the proliferative activity and viability of human breast cancer cells.
Comprehensive in vitro and in vivo study using various experimental model systems showed that the hydrophilic gel for implantation "Activegel" is non-toxic.
评估具有药理活性的物质的生物安全性对于确定其医学用途的可行性至关重要。对于不同来源的物质作为植入物的使用存在争议问题。
我们已经进行了全面的研究，以确定新一代亲水性凝胶植入物（物质的生产名称为“Activegel”）的体内毒性和体外遗传毒性，详细描述其特性并评估其生物安全性。
体内研究表明，动物没有出现中毒的临床表现，其生理状况、一般和生化血液测试也没有异常。对凝胶应用部位的评估显示没有炎症反应，并证明动物皮肤组织处于正常状态。遗传毒性测试的结果表明，凝胶不影响 DNA 彗星参数和微核的形成，因此对人外周血淋巴细胞没有遗传毒性作用。在研究凝胶对体外恶性转化细胞的影响时，发现植入用亲水凝胶“Activegel”不会改变人乳腺癌细胞的增殖活性和活力。
使用各种实验模型系统进行的综合体外和体内研究表明，植入用亲水性凝胶“Activegel”是无毒的。
