Patent No. EP4114476 (titled "A Method For Producing A Decellularized Tissue Scaffold") was filed by Tissue Regenix on Mar 5, 2021. The application was issued on Mar 19, 2025.
A method for producing a decellularized tissue scaffold utilizes starting tissue selected from skin, meniscus, tendon, ligament, cartilage, muscle, or blood vessels. The process comprises incubating the tissue with a polar solvent delipidating agent, an anionic detergent, and a DNA removal agent. To lyse cells and improve biocompatibility by reducing detergent residues, the tissue is incubated at least once with a hypotonic solution and at least once with a hypertonic solution, and/or subjected to at least one freeze/thaw cycle. The method may further include rinsing steps, incubation with an antimicrobial agent (e.g., peracetic acid), and exposure to ionizing radiation (15–50 kGy) for sterilization. Notably, the process can achieve decellularization without requiring animal-derived protease inhibitors like aprotinin.

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