T/LNSI 007-2024 Human Amniotic Mesenchymal Stem Cell Bank

Scope

Main Technical Content: 8 Technical Requirements 8.1 Raw Materials and Auxiliary Materials 8.1.1 They shall comply with the requirements of T/CSCB 0009-2022. 8.1.2 Standards for donor assessment and screening, collection methods, transportation standards, and handover procedures for donor cells shall be established to ensure the safety of donors and cells. 8.1.3 Donors shall be screened for HIV, HBV, HCV, HTLV, EBV, HCMV, and TP, and the results shall be recorded. 8.2 Collection and Cultivation Methods 8.2.1 Sample Collection 8.2.1.1 Human amniotic tissue samples shall be collected by professional medical personnel. 8.2.1.2 The collection site for amniotic membranes shall meet the requirements of a Class III clean operating room. 8.2.2 Sample Transportation 8.2.2.1 Sample transport personnel shall be trained and qualified professionals. 8.2.2.2 The transport temperature of amniotic membrane samples shall be maintained between 2°C and 8°C, and the storage time after removal from the body shall not exceed 24 hours. 8.2.2.3 The transportation process shall be controlled and documented. 8.2.3 Sample Receipt 8.2.3.1 Upon receiving the samples, check the container for any damage and record it. 8.2.3.2 Verify that the information in the "Sample Collection Information Record Form" is complete and correct, and then uniquely label the samples. 8.2.3.3 Disinfect the outer surface of the container with 75% medical alcohol. Accept the samples that meet the testing standards and reject and destroy those that fail the testing. 8.2.4 Separation and Extraction Cut the human amniotic tissue samples into slices and remove the amniotic epithelial cells by trypsin digestion. Then shred the human amniotic tissue and isolate human amniotic mesenchymal stem cells using collagenase digestion. Conduct primary culture of human amniotic mesenchymal stem cells. 8.2.5 Cultivation of Human Amniotic Mesenchymal Stem Cells Replace the culture medium and pas

Development Information

Related Standards