Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that two additional clinical trial filings for its VUM02 (human umbilical cord-derived mesenchymal stem cells) have been accepted for review by the Center for Drug Evaluation (CDE). The Chinese firm is seeking clinical approval for this Category 1 therapeutic biologic product to treat chronic plus acute (subacute) liver failure and acute respiratory distress syndrome (ARDS).
Product Development and Indications
VUM02 is an in-house developed cryopreserved stem cell preparation derived from umbilical cord tissue of healthy fetuses. It undergoes isolation, screening, and amplification in vitro to ensure its quality and efficacy. The product is being developed to address the unmet medical needs of patients with chronic plus acute (subacute) liver failure and ARDS. Currently, there is no similar product available on the market for these indications.
Significance of the Clinical Trials
The acceptance of these clinical trial filings by the CDE marks a significant milestone in the development of VUM02. This innovative stem cell therapy has the potential to offer new treatment options for patients suffering from severe liver and respiratory conditions, expanding the therapeutic landscape in these areas.-Fineline Info & Tech
