R&D Research team, Inventage Lab Inc. Jungwon-gu, Seongnam, 13438, Gyeonggi, Korea.
Department of Life Science, Sogang University, Seoul, 04107, Korea.
Aesthetic Plast Surg. 2021 Aug;45(4):1792-1801. doi: 10.1007/s00266-021-02295-3. Epub 2021 Apr 19.
Poly-L-lactic acid (PLLA) is widely used in tissue engineering. The natural polymer hyaluronic acid (HA) shows excellent biocompatibility and affects cell signaling, proliferation, and differentiation. In addition, a polynucleotide (PN) induces cell growth of human skin fibroblasts and osteoblasts.
In this study, we evaluated the properties, safety, and efficacy of a novel composite filler consisting of cross-linked HA with PN in combination with monodisperse PLLA microspheres manufactured using Inventage Lab Precision Particle Fabrication method.
The composition of the filler and characteristics of the microspheres were examined via scanning electron microscopy, particle size analysis, gel permeation chromatography, and rheology and osmolality measurement. Additionally, safety and efficacy of HA-PN/PLLA composite filler were conducted in in vitro and in vivo.
Analysis of PLLA microspheres revealed spherical surfaces and a narrower particle size distribution than that in PLLA filler. HA-PN/PLLA composite filler had higher viscosity and elasticity values and similar osmolality as compared to those of HA and PN fillers. The nontoxicity in in vitro and in vivo tests reflected that the composite filler may be safe for human use. In addition, the composite filler maintained a more stable volume than did HA filler for 24 weeks after administration in HWY/Slc hairless rats. Furthermore, the results support the effect of HA-PN/PLLA in restoring skin structure.
Altogether, these data suggest that the novel composite filler might be a safe and effective option in terms of tissue integration, clinical management during delivery and high esthetic durability.
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聚左旋乳酸（PLLA）广泛应用于组织工程学。天然聚合物透明质酸（HA）具有极好的生物相容性，并影响细胞信号转导、增殖和分化。此外，多核苷酸（PN）可诱导人皮肤成纤维细胞和骨细胞的生长。
本研究评估了由与 PN 交联的 HA 与使用 Inventage Lab 精密颗粒制造方法制造的单分散 PLLA 微球组成的新型复合填充剂的特性、安全性和疗效。
通过扫描电子显微镜、粒径分析、凝胶渗透色谱、流变学和渗透压测量来检查填充剂的组成和微球的特性。此外，还在体外和体内研究了 HA-PN/PLLA 复合填充剂的安全性和疗效。
对 PLLA 微球的分析表明，其表面呈球形，粒径分布比 PLLA 填充剂更窄。HA-PN/PLLA 复合填充剂的粘度和弹性值较高，渗透压与 HA 和 PN 填充剂相似。体外和体内非毒性试验表明，该复合填充剂可能对人体安全。此外，与 HA 填充剂相比，在 HWY/Slc 无毛大鼠中给药 24 周后，该复合填充剂的体积更稳定。此外，结果支持了 HA-PN/PLLA 恢复皮肤结构的效果。
总的来说，这些数据表明，新型复合填充剂在组织整合、输送过程中的临床管理以及高美观持久性方面可能是一种安全有效的选择。
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