Regenerative Nano-scaffolds for Tissue Engineering: From Bench to Clinical Translation

Abstract

Biomedical membranes are among the most widely used biomaterials in clinical regenerative medicine due to their ease of application, biocompatibility, and versatility across multiple tissues. However, conventional membranes have been limited to passive roles serving as physical barriers or wound coverings without an intrinsic capability to initiate or orchestrate true tissue regeneration. Here, we report the design, development, and clinical validation of an active tissue-regenerative biomedical membrane patch, aiming to advance biomedical membranes from passive protection toward active human tissue regeneration. In this study, we developed a multifunctional, collagen-coated polylactic-co-glycolic acid nanotopographical scaffold (Col-NS) that mimics the native extracellular matrix to enhance soft- and hard-tissue regeneration. In a clinical trial for laser-induced human skin injury, Col-NS substantially improved healing outcomes, achieving accelerated wound contraction, dermal volume restoration, reduced surface roughness, and decreased transepidermal water loss relative to standard care. In human dental procedures, including alveolar ridge preservation and guided bone regeneration, Col-NS enabled robust bone formation, stable implant osseointegration, and complication-free recovery. These findings demonstrate the translational feasibility of an extracellular-matrix-mimetic nanoengineered scaffold across soft- and hard-tissue applications and support its potential as a clinically relevant platform for regenerative medicine. This work may contribute to broadening the clinical role of biomedical patches from passive coverings toward active regenerative platforms.