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T/CI 307-2024 Active
T/CI 307-2024 The quality requirements for mesenchymal stem cells used for disease treatment
Abstract
This document specifies the key biological properties, biological efficacy, safety, labeling, packaging, storage, transportation, and testing report requirements for human mesenchymal stem cells (MSCs) used in disease treatment, defines the indicators for high-quality MSCs, provides basic parameters for identifying whether MSCs have replicative senescence, and sets forth the basic quality requirements for MSCs used in specific indications. This document is applicable to the research, development, production, and clinical application of human mesenchymal stem cells and their products used in disease treatment.
General Product Information
| Document Type | Group standards |
|---|---|
| Standard Status | Active |
| Standard Code | T/CI 307-2024 |
| CCS | Medicine |
| ICS | Biology, botany, and zoology |
| Implement Date | 2024-03-21 |
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