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The application of human mesenchymal stromal cells (hMSCs) in regenerative medicine and cell therapies demands a high level of precision and reliability in both research and clinical settings. Achieving these standards requires stringent adherence to quality management systems, such as ISO 17025, which ensures the competence of laboratories conducting testing and calibration. ISO 17025 certification for a Cell Therapy Center provides a framework for ensuring that laboratory operations, including cell culture, processing, and characterization, are conducted in a reliable, reproducible, and compliant manner.For MSC-based therapies, ISO 17025 plays a crucial role in validating critical quality control (QC) tests​.

By adhering to ISO 17025, a Cell Therapy Center guarantees that all aspects of MSC production and testing are conducted under controlled, validated conditions, ensuring traceability and reproducibility in preparation for clinical use. This certification strengthens the credibility and regulatory compliance of the facility, providing confidence in the safety, efficacy, and consistency of MSC-based therapies and advancing their potential in regenerative medicine.​

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