美国食品和药物管理局 (FDA) 首次批准美中细胞质量标准, 提高再生医学的可靠性. FDA accepts first U.S. quality standard for mesenchymal stromal cells, boosting regenerative medicine reliability.

美国食品和药物管理局已经接受了"MSCs Assay的Tasly 3P特性测试"的设备主文件,为美国中细胞结构细胞建立了第一个正式的质量控制标准. The FDA has accepted a Device Master File for the "Tasly 3P Characterization of MSCs Assay," establishing the first formal quality control standard for mesenchymal stromal cells in the U.S. 该议定书于2026年1月9日确认,评估细胞特征、纯度和效力,以确保以MSC为基础的治疗方法的一致性和安全性。 The protocol, acknowledged on January 9, 2026, evaluates cell identity, purity, and potency to ensure consistency and safety in MSC-based therapies. 这一举动解决了长期存在的细胞质量和临床结果的变化,与MSC主要通过副膜信号工作的当前科学一致. This move addresses longstanding variability in cell quality and clinical outcomes, aligning with current science that MSCs work primarily through paracrine signaling. 预计该标准将提高试验可靠性,简化监管程序,并增强对再生医学治疗的信心。 The standard is expected to improve trial reliability, streamline regulatory processes, and boost confidence in regenerative medicine treatments.