天士力同种异体脂肪间充质基质细胞注射液启动Ⅰ期临床 适应症为急性缺血性卒中

Group 1 - The clinical trial for Tianjin Tasly Pharmaceutical Group Co., Ltd.'s allogeneic adipose-derived mesenchymal stem cell injection (B2065) for treating acute ischemic stroke has been initiated, with the trial registration number CTR20255104 and the first public information date set for December 26, 2025 [1] - The drug is administered via intravenous infusion in three dosage groups: 1 bag, 3 bags, and 9 bags, with an infusion time of approximately 20 minutes (±2 minutes) per bag, and the treatment is a single administration [1] - The primary objective of the trial is to evaluate the safety and tolerability of B2065, while secondary objectives include assessing the preliminary clinical efficacy and exploring the mechanism and immunogenicity of B2065 [1] Group 2 - The main endpoints of the trial include the incidence of dose-limiting toxicities (DLT) during the dose escalation phase, adverse events, vital signs, all-cause mortality rates at 14 days, 12 months, and 24 months, and tumor formation observations at 6 months and 24 months [2] - Secondary endpoints consist of the proportion of participants with mRS scores of 0-2 and 0-1 at different time points, the proportion of participants with a decrease in NIHSS score of ≥4 (NIHSS score ≤1), the proportion of participants with BI scores of 95-100, and EQ-5D-5L scores [2] - The current status of the trial is ongoing (not yet recruiting), with a target enrollment of 36 participants [2]