Amniotic membrane (AM) has been shown to enhance corneal wound healing due to the abundance of growth factors, cytokines, and extracellular matrix (ECM) proteins inherent to the tissue. As such, AM has garnered widespread clinical utility as a biological dressing for a number of ophthalmic and soft tissue applications. The preparation, sterilization, and storage procedures used to manufacture AM grafts are extremely important for the conservation of inherent biological components within the membrane. Current processing techniques use harsh chemicals and sterilization agents that can compromise the fundamental wound healing properties of AM. Furthermore, commercially available cryopreserved AM products require specific storage conditions (e.g., ultra-low freezers) thereby limiting their clinical availability in austere environments. Supercritical carbon dioxide (SCCO₂) technology allows for the sterilization of biological tissues without the resulting degradation of integral ECM proteins and other factors often seen with current tissue sterilization processes. With this study we demonstrate that lyophilized AM, sterilized using SCCO₂, maintains similar biochemical properties and biocompatibility as that of commercially available AM products requiring specialized cold storage conditions.

由于组织固有的大量生长因子、细胞因子和细胞外基质 (ECM) 蛋白，羊膜 (AM) 已被证明可以促进角膜伤口愈合。因此，AM 作为生物敷料在许多眼科和软组织应用中获得了广泛的临床应用。用于制造 AM 移植物的制备、灭菌和储存程序对于保护膜内固有的生物成分极为重要。当前的加工技术使用刺激性化学品和消毒剂，可能会损害 AM 的基本伤口愈合特性。此外，市售的冷冻保存 AM 产品需要特定的储存条件（例如，超低温冰箱），从而限制了它们在严峻环境中的临床可用性。₂ ) 技术允许对生物组织进行灭菌，而不会导致整体 ECM 蛋白的降解和当前组织灭菌过程中常见的其他因素。通过这项研究，我们证明使用 SCCO ₂灭菌的冻干 AM保持与需要专门冷藏条件的市售 AM 产品相似的生化特性和生物相容性。