T/LNSI 008-2024 Human umbilical cord mesenchymal stem cells

Scope

Main Technical Content: 5. Technical Requirements 5.1 Raw Materials and Auxiliary Materials 5.1.1 They shall comply with the requirements of T/CSCB 0001-2022. 5.1.2 Standards for donor evaluation and screening, collection methods, transportation standards, and handover standards for donor cells shall be established to ensure the safety of donors and cells. 5.1.3 Donors shall be screened for HIV, HBV, HCV, HTLV, EBV, HCMV, and TP, and the results shall be recorded. 5.2 Separation and Cultivation Methods 5.2.1 Separation and extraction of umbilical cord mesenchymal stem cells from Whartin's jelly tissue using the tissue block adherence method. Primary culture of human umbilical cord mesenchymal stem cells shall be performed. 5.2.2 Human umbilical cord mesenchymal stem cells shall be replaced with fresh medium based on their growth status. 5.2.3 Passage of human umbilical cord mesenchymal stem cells shall be performed with appropriate density, timely, and rapidly. 5.2.4 Cryopreservation of human umbilical cord mesenchymal stem cells shall be carried out by cooling the cells and storing them in liquid nitrogen. 5.2.5 Thawing of human umbilical cord mesenchymal stem cells shall be performed by removing the cryopreservation tube, rapid thawing, and centrifugal washing before cultivation. 5.2.6 Solution of human umbilical cord mesenchymal stem cells shall be a homogeneous state without flocculent sediment, and the cell survival rate shall be ≥90%. 5.3 Key Quality Attributes 5.3.1 Cell Morphology When cultured on a substrate, the cells shall present a spindle-shaped and fusiform fibroblast phenotype with uniform morphology. 5.3.2 Chromosomal Karyotype The normal karyotype shall be 46,XX or 46,XY, and no chromosomal abnormalities shall be observed in the 400-550 band stage. 5.3.3 Cell Survival Rate The survival rate of unfrozen cells shall be ≥90%, and the survival rate after thawing and cultivation shall be ≥70%. 5.3.4 Cell Marker P

Development Information

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