China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced receiving clinical trial approvals from the National Medical Products Administration (NMPA) for its VUM02, a human umbilical cord-derived mesenchymal stem cell therapy. The Category 1 therapeutic biologic product is set to be assessed in acute-on-chronic liver failure (ACLF) and moderate and severe acute respiratory distress syndrome (ARDS).
VUM02: An Innovative Stem Cell Preparation
VUM02 is an in-house developed cryopreserved stem-cell preparation derived from umbilical cord tissue of healthy fetuses after isolation, screening, and amplification in vitro. The therapy is being developed to treat patients with ACLF, ARDS, and other conditions, offering a potential new avenue for treatment in these areas.
Addressing Unmet Needs in ACLF and ARDS
ACLF is typically accompanied by acute jaundice deepening, coagulation dysfunction, and is a dangerous condition with no specific clinical medication available. Liver transplantation is currently the only proven effective treatment method, but the scarcity and high cost of donors make it difficult to meet patient needs. Mesenchymal stem cells have shown good safety and tolerance in treating ACLF and can exert pharmacological effects by inhibiting inflammatory reactions, promoting liver cell regeneration and liver tissue repair, and alleviating liver fibrosis.
ARDS is characterized by diffuse inflammatory alveolar and pulmonary capillary damage and rapid onset hypoxemia, with no targeted therapy currently available. Mesenchymal stem cell therapy for ARDS is safe and well tolerated, improving lung function in patients through immune regulation, regulation of endothelial and epithelial cell permeability, improvement of alveolar fluid clearance rate, promotion of lung tissue repair, and delay of fibrosis in the later stages of ARDS.-Fineline Info & Tech
