Microbial Contamination Control and Related Standards for Human Stem Cell Preparations
10.12290/xhyxzz.2024-0586
- VernacularTitle:人源干细胞制剂微生物污染控制及相关规范
- Author:
Cuizhu CHEN
1
;
Changfa HUANG
;
Qian LI
;
Ze WU
;
Chunran CAO
;
Zhihong WU
Author Information
1. 中国医学科学院北京协和医院 临床医学研究所,北京 100730;中国医学科学院北京协和医院 转化医学国家重大科技基础设施,北京 100730
- Publication Type:Journal Article
- Keywords:
stem cells;
clinical therapy;
microbe;
quality control
- From:
Medical Journal of Peking Union Medical College Hospital
2025;16(6):1429-1436
- CountryChina
- Language:Chinese
-
Abstract:
Human stem cell preparations and related products have been widely utilized in clinical trials and treatments for refractory diseases both domestically and internationally.Due to the complexity of the prepa-ration process for stem cell preparations,current microbial detection methods struggle to meet the safety testing requirements,particularly for release testing within medical institutions.Therefore,it is imperative to develop novel alternative methods to ensure the safe and timely clinical application of stem cell preparations.This article elaborates on the microbial testing procedures and relevant regulatory standards involved in stem cell preparations,covering aspects such as raw material selection,preparation processes,release testing,therapeutic application,and sample retention testing.The aim is to provide a foundation for microbial quality control in the clinical use of stem cell preparations.
