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| T/CI 307-2024 Quality requirements of mesenchymal stem cells for therapy (English Version) |
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Detail of T/CI 307-2024
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Introduction of T/CI 307-2024
本文件规定了用于疾病治疗的人体间充质干细胞（MSCs)的关键生物学性质、生物效力、安全性、标签、包装、储存、运输、检测报告的要求，界定了是否是优质MSCs的指标，给出了鉴定MSCs有无复制性衰老的基本参数，提供了用于特定适应症MSCs的基本质量要求。本文件适用于疾病治疗的人体间充质干细胞及其制品的研发、生产和临床应用。
Contents of T/CI 307-2024