T/LNSI 006-2024 Human amniotic epithelial 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 evaluation 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 of amniotic membranes shall meet the requirements of Class III clean operating rooms. 8.2.2 Sample Transportation 8.2.2.1 Sample transport personnel shall be trained and qualified professionals. 8.2.2.2 The transportation 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 records shall be maintained. 8.2.3 Sample Receipt 8.2.3.1 Upon receiving the samples, check the integrity of the container and record any damage. 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 detection standards and reject and destroy those that do not meet the standards, keeping proper records. 8.2.4 Isolation and Extraction of Human Amniotic Tissue Samples - Cut the samples into slices and separate human amniotic epithelial stem cells by enzymatic digestion. - Perform primary culture of human amniotic epithelial stem cells. 8.2.5 Cultivation of Human Amniotic Epithelial Stem Cells - Change the culture medium and pass the cells according to

Development Information

Related Standards