Scaffold-free cell sheet therapies: clinical advances, global approval landscapes, and strategic directions to address regenerative medicine barriers.

ABSTRACT: Cell sheet therapy has emerged as a transformative technology in regenerative medicine, providing scaffold-free constructs that preserve cell-cell junctions and extracellular matrix components. Compared with traditional cell delivery methods, cell sheets enable improved engraftment, survival, and integration after transplantation. Recent years have witnessed remarkable progress in clinical translation, with several products approved in Japan, the United States, and South Korea. This review summarizes the current landscape of cell sheet therapies approved worldwide, focusing on their fabrication technologies, cell sources, and clinical indications. We highlight representative products such as JACE^®, Nepic^®, Ocural^®, JACEMIN^®, HeartSheet^®

SUBMITTER: Lin A 

PROVIDER: S-EPMC12771818 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature