From Production to the Clinic: Decellularized Extracellular Matrix as a Biomaterial for Tissue Engineering and Regenerative Medicine.

Biomaterials made with extracellular matrix obtained from allogeneic or xenogeneic tissues/organs or cultured cells have excellent biochemical and physical properties in supporting cell growth and tissue regeneration. These decellularized extracellular matrix-based biomaterials have been applied in clinical trials and have bright prospects in tissue engineering and regenerative medicine. Here, we systematically compare organ-derived and cell-derived decellularized extracellular matrix, summarize commonly used decellularization methods, including physical, chemical, and biological/enzymatic treatments, as well as combinations of these treatments, and characterize methods for decellularization, including histological staining, immunohistochemical techniques, biochemical analysis, scanning electron microscopy, and mechanical stress testing. Besides the production of decellularized extracellular matrix, the evolving intellectual property landscape and commercial products are also introduced. A significant focus is placed on summarizing clinical trial outcomes, demonstrating the efficacy of decellularized extracellular matrix scaffolds in diverse applications, including wound healing, cardiovascular repair, nerve regeneration, and breast reconstruction. Finally, we discuss persistent challenges and future directions, underscoring the translational potential of decellularized extracellular-matrix-based strategies for restoring tissue structure and function.