Amnion-Based Biomaterials for Musculoskeletal Regenerative Engineering

Purpose Amnion is used as a biomaterial for musculoskeletal tissue regeneration due to its unique properties, including biocompatibility, low immunogenicity, anti-inflammatory, anti-fibrosis, and accelerating wound healing. In addition, the presence of stem cells within the amnion tissue further enriches the regenerative potential of this tissue. Although several decellularized amnion products are commercially available, the use of amnion for musculoskeletal tissue regeneration is a growing area of research. Concerns with isolation, preparation, processing, sterility, limited clinical evidence, and increased regulatory scrutiny of regenerative medicine therapies have created significant barriers in its clinical translation. This review paper aims to provide a comprehensive review of amnion structure, types of amnion-derived cells, biological properties, their mechanisms in various musculoskeletal tissue regeneration, and the current status of clinical translation of amnion-derived materials. Methods A search of Google Scholar and PubMed has been performed using a combination of keywords. A review of the characteristics of amnion is presented. Preclinical and clinical studies using amnion membrane or amnion-derived stem cells as biomaterials were summarized. Results Numerous articles have suggested the potential of amnion-based biomaterials for musculoskeletal tissue regeneration. Conclusion Considering the unique properties of amnion and its use in basic sciences, preclinical and clinical studies may lead to a breakthrough in regenerative engineering applications. Broader applications and extensive assessment of amnion use for tissue regeneration would require standardized preparation, processing, and storage methods followed by high-quality preclinical studies and randomized clinical trials. Lay Summary The amnion is a protective layer surrounding a developing fetus, and its unique properties have generated interest in using it as a biomaterial in musculoskeletal tissue regeneration. In addition, the presence of stem cells within the amnion tissue further enriches the regenerative potential of this tissue. However, concerns with isolation, preparation, processing, sterility, limited clinical evidence, and increased regulatory scrutiny of regenerative medicine therapies have created significant barriers in its clinical translation. Thus, broader applications and extensive assessment of amnion membrane and amnion-derived stem cells used for tissue regeneration would require standardized preparation, processing, and storage methods followed by high-quality preclinical studies and randomized clinical trials.