Protease-Mediated Recovery of Amnion from Placenta and Its Application as a Bioprocessed Therapeutic Biomaterial for Wound Healing

Objective: Wound healing presents significant challenges to healthcare systems, particularly in the management of chronic wounds. Amnion, a collagen-rich membrane traditionally discarded after childbirth, has shown promise in skin regenerative medicine due to its anti-inflammatory, antimicrobial, and biocompatible properties. However, conventional methods for separating amnion from the placenta often result in tissue damage and inconsistent material quality, limiting their therapeutic potential. This study introduces an enzymatic process using Bacillus sp. S2 MTCC 13117 protease to separate the amnion from the placenta while preserving its collagen structure and mechanical properties. Material and Methods: The enzymatic treatment effectively removes non-collagenous proteins and epithelial layers, creating high-quality amnion suitable for wound-healing applications. Biophysical characterization of the biomaterials demonstrated suitable tensile strength, permeability to oxygen and water vapor, and high surface area, all critical for effective wound coverage and healing. Results: In vitro studies showed that amnion scaffolds promoted fibroblast proliferation with low toxicity and high biocompatibility, while in vivo rat models indicated significantly faster wound healing, with complete closure observed in 7 days compared to 12–14 days for controls. Histological analysis confirmed enhanced collagen organization and skin structure regeneration in treated wounds. Conclusion: These results demonstrate that enzymatically processed amnion scaffolds are an effective and cost-efficient alternative for wound care, with superior healing outcomes compared to conventional therapies. This study supports the use of amnion-derived biomaterials in treating chronic wounds, including diabetic and venous leg ulcers.