Banking Human Umbilical Cord-Derived Mesenchymal Stromal Cells for Clinical Use
Authors: Gong, Wei; Han, Zhibo; Zhao, Hui; Wang, Youwei; Wang, Jiming; Zhong, Jian; Wang, Bin; Wang, Shanshan; Wang, Yongjuan; Sun, Lingyun; Han, Zhongchao
Source: Cell Transplantation, Volume 21, Number 1, 2012 , pp. 207-216(10)
Publisher: Cognizant Communication Corporation
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 × 108 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.
Document Type: Research Article
Affiliations: National Engineering Research Center of Cell Products, AmCellGene Co. Ltd, TEDA, Tianjin, China
Publication date: 2012-01-01
- Cell Transplantation publishes original, peer-reviewed research and review articles on the subject of cell transplantation and its application to human diseases. To ensure high-quality contributions from all areas of transplantation, separate section editors and editorial boards have been established. Articles deal with a wide range of topics including physiological, medical, preclinical, tissue engineering, and device-oriented aspects of transplantation of nervous system, endocrine, growth factor-secreting, bone marrow, epithelial, endothelial, and genetically engineered cells, among others. Basic clinical studies and immunological research papers are also featured. To provide complete coverage of this revolutionary field, Cell Transplantation will report on relevant technological advances, and ethical and regulatory considerations of cell transplants. Cell Transplantation is now an Open Access journal starting with volume 18 in 2009, and therefore there will be an inexpensive publication charge, which is dependent on the number of pages, in addition to the charge for color figures. This will allow work to be disseminated to a wider audience and also entitle the corresponding author to a free PDF, as well as prepublication of an unedited version of the manuscript.
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- In this Subject: Anatomy & Physiology , Biology , Biotechnology , Pharmacology , Surgery
- By this author: Gong, Wei ; Han, Zhibo ; Zhao, Hui ; Wang, Youwei ; Wang, Jiming ; Zhong, Jian ; Wang, Bin ; Wang, Shanshan ; Wang, Yongjuan ; Sun, Lingyun ; Han, Zhongchao