In this study, clinoptilolite (CLN) was employed as a reinforcement in a polymer-based composite scaffold in bone tissue engineering and evaluated in vivo for the first time. Highly porous, mechanically stable, and osteogenic CLN/PCL-PEG-PCL (CLN/PCEC) scaffolds were fabricated with modified particulate leaching/compression molding technique with varying CLN contents. We hypothesized that CLN reinforcement in a composite scaffold will improve bone regeneration and promote repair. Therefore, the scaffolds were analyzed for compressive strength, biodegradation, biocompatibility, and induction of osteogenic differentiation in vitro. CLN inclusion in PC-10 (10% w/w) and PC-20 (20% w/w) scaffolds revealed 54.7% and 53.4% porosity, higher dry (0.62 and 0.76 MPa), and wet (0.37 and 0.45 MPa) compressive strength, greater cellular adhesion, alkaline phosphatase activity (2.20 and 2.82 mg/gDNA /min), and intracellular calcium concentration (122.44 and 243.24 g Ca/mgDNA ). The scaffolds were evaluated in a unicortical bone defect at anterior aspect of proximal tibia of adult rabbits 4 and 8 weeks postimplantation. Similar to in vitro results, CLN-containing scaffolds led to efficient regeneration of bone in a dose-dependent manner. PC-20 demonstrated highest quality of bone union, cortex development, and bone-scaffold interaction at the defect site. Therefore, higher CLN content in PC-20 permitted robust remodeling whereas pure PCEC (PC-0) scaffolds displayed fibrous tissue formation. Consequently, CLN was proven to be a potent reinforcement in terms of promoting mechanical, physical, and biological properties of polymer-based scaffolds in a more economical, easy-to-handle, and reproducible approach.

中文翻译：

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用于骨骼再生的复合斜发沸石/ PCL-PEG-PCL支架：体外和体内评估。

在这项研究中，斜发沸石（CLN）被用作骨组织工程中基于聚合物的复合支架的增强材料，并首次在体内进行了评估。用改良的颗粒浸出/压缩成型技术制造具有高度多孔性，机械稳定性和成骨性的CLN / PCL-PEG-PCL（CLN / PCEC）支架，并改变CLN含量。我们假设复合支架中的CLN增强将改善骨骼再生并促进修复。因此，在体外分析了支架的抗压强度，生物降解，生物相容性和成骨分化的诱导。在PC-10（10％w / w）和PC-20（20％w / w）支架中包含CLN时显示出54.7％和53.4％的孔隙率，较高的干度（0.62和0.76 MPa）和湿润的（0.37和0.45 MPa）抗压强度，更大的细胞粘附力，碱性磷酸酶活性（2.20和2.82 mg / gDNA / min）和细胞内钙浓度（122.44和243.24 g Ca / mgDNA）。在植入后4周和8周，评估成年兔胫骨近端前侧单皮质骨缺损的支架。与体外结果相似，含CLN的支架以剂量依赖性方式导致骨的有效再生。PC-20在缺损部位表现出最高的骨结合，皮质发育和骨-支架相互作用质量。因此，PC-20中较高的CLN含量可实现强大的重塑，而纯PCEC（PC-0）支架则显示出纤维组织的形成。因此，事实证明，CLN可以有效地增强聚合物基脚手架的机械，物理和生物学特性，并且更经济，更易于操作，