title: Banking human umbilical cord-derived mesenchymal stromal cells for clinical use.
abstract: A great deal of interest has arisen recently with respect to human mesenchymal stem cells (MSCs), due to their broad therapeutic potential. However, the safety and efficacy of MSCs expanded ex vivo for clinical applications remain a concern. In this article, we establish a standardized  process for manufacture of human umbilical cord-derived MSCs (UC-MSCs), which encompasses donor screening and testing, recovery, two-stage expansion, and administration. The biological properties and safety of UC-MSCs were then characterized and tested. The safety data from use in human patients  have also been reported. After clinical-scale expansion, a yield of 1.03-3.78 × 10(8) MSCs was achieved in 10 batch manufacturing runs. The biological properties, such as plastic adherence, morphology, specific surface antigen (CD105, CD73, CD90, positive ≥ 95%; CD45,  CD34, CD31, CD11b, CD19, HLA-DR, negative ≤2%), and multipotent differentiation potential (osteogenesis and adipogenesis) were retained. Bacterial and mycoplasma tests were negative and endotoxin levels were lower than 2 EU/ml. No adverse events were noted in two patients treated with intravenously  and/or intrathecally administered MSCs. The data obtained indicate that banking UC-MSCs for clinical use is feasible.
authors.affiliation: National Engineering Research Center of Cell Products, AmCellGene Co. Ltd, TEDA, Tianjin, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Gong
authors.forename: Zhibo
authors.initials: Z
authors.lastname: Han
authors.forename: Hui
authors.initials: H
authors.lastname: Zhao
authors.forename: Youwei
authors.initials: Y
authors.lastname: Wang
authors.forename: Jiming
authors.initials: J
authors.lastname: Wang
authors.forename: Jian
authors.initials: J
authors.lastname: Zhong
authors.forename: Bin
authors.initials: B
authors.lastname: Wang
authors.forename: Shanshan
authors.initials: S
authors.lastname: Wang
authors.forename: Yongjuan
authors.initials: Y
authors.lastname: Wang
authors.forename: Lingyun
authors.initials: L
authors.lastname: Sun
authors.forename: Zhongchao
authors.initials: Z
authors.lastname: Han
mesh_terms: D000328:Adult; D018070:Biological Specimen Banks; D018929:Cell Culture Techniques; D002454:Cell Differentiation; D049109:Cell Proliferation; D002470:Cell Survival; D002478:Cells, Cultured; D036101:Cord Blood Stem Cell Transplantation; D015925:Cryopreservation; D005260:Female; D006801:Humans; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation; D059630:Mesenchymal Stem Cells / Q000166:cytology / Q000276:immunology; D008875:Middle Aged; D014470:Umbilical Cord / Q000166:cytology*