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Allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) developed by Tianjin AmCellGene Engineering is an off-the-shelf, GMP-grade cell therapy product. The therapy consists of cryopreserved third-party UC-MSCs formulated with DMSO and human serum albumin, requiring thawing prior to administration. It functions through mesenchymal stem cell-mediated immunomodulation, anti-inflammation, and tissue repair/regeneration. The China National Medical Products Administration (NMPA) has approved clinical trials for this product across several indications, including graft-versus-host disease (GVHD), acute-on-chronic liver failure (ACLF), acute ischemic stroke, refractory immune thrombocytopenia (ITP), and severe aplastic anemia. The product is currently being evaluated in Phase I and Phase II clinical trials.
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