| 讲座 |
|
|
|
|
| 细胞药物的标准及质量控制——细胞药物连载之四 |
| 王佃亮 |
| 中国人民解放军火箭军总医院药学部组织工程与再生医学实验室 北京 100088 |
|
| The Standards and Quality Control of Cell Drug |
| WANG Dian-liang |
| Tissue Engineering and Regenerative Medicine Laboratory, The General Hospital of The PLA Rocket Force, Beijing 100088, China |
| [1] Domen J, Christensen J L, Gille D, et al.Cryopreserved ex vivo-expanded allogeneic myeloid progenitor cell product protects neutropenic mice from a lethal fungal infection. Cell Transplant,2016,25(1):17-33.
[2] Dergacheva T I, Lykov A P, Shurlygina A V, et al. Parameters of microcirculation in the broad ligament of the uterus in Wistar rats after injection of autologous biomedical cell product. Bull Exp Biol Med, 2015,159(6):786-788.
[3] Zhang W, Smythe J, Frith E, et al.An innovative method to generate a good manufacturing practice-ready regulatory T-cell product from non-mobilized leukapheresis donors.Cytotherapy,2015,17(9):1268-1279.
[4] Bachier C, Potter J, Potter G, et al.High white blood cell concentration in the peripheral blood stem cell product can induce seizures during infusion of autologous peripheral blood stem cells. Biol Blood Marrow Transplant, 2012, 18(7):1055-1060.
[5] Lasala G P, Silva J A, Minguell J J. Therapeutic angiogenesis in patients with severe limb ischemia by transplantation of a combination stem cell product. J Thorac Cardiovasc Surg, 2012,144(2):377-382.
[6] Wright C, Velickovic Z, Brown R, et al. Raising the standard: changes to the Australian Code of Good Manufacturing Practice (cGMP) for human blood and blood components, human tissues and human cellular therapy products.Pathology,2014,46(3):177-183.
[7] Jones M, Varella-Garcia M, Skokan M, et al. Genetic stability of bone marrow-derived human mesenchymal stromal cells in the Quantum System.Cytotherapy, 2013,15(11):1323-1339.
[8] Dominici M, Le Blanc K, Slaper-Cortenbach I, et al. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy,2006,8:315-331.
[9] Volpe G, Delibato E, Fabiani L, et al. Development and evaluation of an ELIME assay to reveal the presence of Salmonella in irrigation water: comparison with real-time PCR and the standard culture method. Talanta, 2016,149:202-210.
[10] Dufrane D, Docquier P L, Delloye C, et al. Scaffold-free three-dimensional graft from autologous adipose-derived stem cells for large bone defect reconstruction: Clinical proof of concept.Medicine (Baltimore),2015,94(50):e2220.
[11] Montemurro T, Viganò M, Budelli S, et al.How we make cell therapy in Italy. Drug Des Devel Ther,2015,9:4825-4834.
[12] Elseberg C L, Salzig D, Czermak P. Bioreactor expansion of human mesenchymal stem cells according to GMP requirements. Methods Mol Biol,2015,1283:199-218.
[13] Gastens M H, Goltry K, Prohaska W, et al. Good manufacturing practice-compliant expansion of marrow-derived stem and progenitor cells for cell therapy.Cell Transplant,2007,16(7):685-696.
[14] Mijovic A, Pamphilon D.Harvesting, processing and inventory management of peripheral blood stem cells. Asian J Transfus Sci,2007,1(1):16-23.
[15] Cobo F, Stacey G N, Hunt C, et al. Microbiological control in stem cell banks: approaches to standardisation. Appl Microbiol Biotechnol,2005,68(4):456-466.
[16] Wen S H, Zhao W L, Lin P Y, et al. Associations among birth weight, placental weight, gestational period and product quality indicators of umbilical cord blood units.Transfus Apher Sci,2012,46(1):39-45.
[17] Ilic N, Brooke G, Murray P, et al. Manufacture of clinical grade human placenta-derived multipotent mesenchymal stromal cells. Methods Mol Biol,2011,698:89-106.
[18] Spohn G, Wiercinska E, Karpova D, et al. Automated CD34+ cell isolation of peripheral blood stem cell apheresis product.Cytotherapy,2015,17(10):1465-1471.
[19] Angbohang A, Wu N, Charalambous T, et al.Downregulation of the canonical WNT signaling pathway by TGFβ1 inhibits photoreceptor differentiation of adult human Müller Glia with stem cell characteristics.Stem Cells Dev, 2016,25(1):1-12.
[20] Lei M, Li K, Li B, et al. Mesenchymal stem cell characteristics of dental pulp and periodontal ligament stem cells after in vivo transplantation. Biomaterials,2014,35(24):6332-6343.
[21] Nicolay N H, Sommer E, Lopez R, et al.Mesenchymal stem cells retain their defining stem cell characteristics after exposure to ionizing radiation. Int J Radiat Oncol Biol Phys, 2013,87(5):1171-1178. |
|
Viewed |
|
|
|
Full text
|
|
|
|
|
Abstract
|
|
|
|
|
Cited |
|
|
|
|
| |
Shared |
|
|
|
|
| |
Discussed |
|
|
|
|
