First decade of clinical trials and published studies with mesenchymal stromal cells from umbilical cord tissue

被引：35
作者：
Couto, Pedro S. [1 ,2 ]
Shatirishvili, Gocha [3 ]
Bersenev, Alexey [4 ]
Verter, Frances [1 ]
机构：
[1] Parents Guide Cord Blood Fdn, Brookeville, MD 20833 USA
[2] UCL, Dept Biochem Engn, London WC1E 7JE, England
[3] Geocord Cord Blood Bank, GE-0186 Tbilisi, Georgia
[4] Yale Univ, Yale New Haven Hosp, Adv Cell Therapy Lab, New Haven, CT 06520 USA
来源：
REGENERATIVE MEDICINE | 2019年 / 14卷 / 04期
关键词：
cell therapy; clinical trial; manufacturing; mesenchymal stromal cells (MSC); umbilical cord tissue; STEM-CELLS; THERAPY; BLOOD;
D O I：
10.2217/rme-2018-0171
中图分类号：
Q813 [细胞工程];
学科分类号：
摘要：
Aim: This is the first analysis of both clinical trials and published studies that employ umbilical cord mesenchymal stromal cells, for the decade 2007-2017. Materials & methods: Searching international databases, we found 178 registered trials and 98 publications. Results: Among the registered clinical trials, 20% have resulted in publications so far. Among the publications, 18% report safety and 74% report some form of improvement. Between 36 and 45% of the publications do not report aspects of the cell manufacturing, including isolation method, culture medium or number of culture passages. Conclusion: Analyses that link trials with publications can elucidate factors that promote study completion and publication. More full disclosure of cell manufacturing is needed to evaluate the efficacy of mesenchymal stromal cell isolated from umbilical cord tissue (UC-MSC) products.
引用
收藏
页码：309 / 319
页数：11
相关论文
共 26 条
[1]  
Abazari A., 2017, Cell Gene Ther Insights, V3, P852, DOI [10.18609/cgti.2017.082, DOI 10.18609/CGTI.2017.082]
[2]   Intraarterial route increases the risk of cerebral lesions after mesenchymal cell administration in animal model of ischemia [J].
Argibay, Barbara ;
Trekker, Jesse ;
Himmelreich, Uwe ;
Beiras, Andres ;
Topete, Antonio ;
Taboada, Pablo ;
Perez-Mato, Maria ;
Vieites-Prado, Alba ;
Iglesias-Rey, Ramon ;
Rivas, Jose ;
Planas, Anna M. ;
Sobrino, Tomas ;
Castillo, Jose ;
Campos, Francisco .
SCIENTIFIC REPORTS, 2017, 7
[3]   Mesenchymal Stromal Cells: Sensors and Switchers of Inflammation [J].
Bernardo, Maria Ester ;
Fibbe, Willem E. .
CELL STEM CELL, 2013, 13 (04) :392-402
[4]   Umbilical cord mesenchymal stromal cell transplantations: A systemic analysis of clinical trials [J].
Can, Alp ;
Celikkan, Ferda Topal ;
Cinar, Ozgur .
CYTOTHERAPY, 2017, 19 (12) :1351-1382
[5]   The MSC: An Injury Drugstore [J].
Caplan, Arnold I. ;
Correa, Diego .
CELL STEM CELL, 2011, 9 (01) :11-15
[6]   Cryopreserved Mesenchymal Stromal Cells Are Susceptible to T-Cell Mediated Apoptosis Which Is Partly Rescued by IFNγ Licensing [J].
Chinnadurai, Raghavan ;
Copland, Ian B. ;
Garcia, Marco A. ;
Petersen, Christopher T. ;
Lewis, Christopher N. ;
Waller, Edmund K. ;
Kirk, Allan D. ;
Galipeau, Jacques .
STEM CELLS, 2016, 34 (09) :2429-2442
[7]   The first decade of advanced cell therapy clinical trials using perinatal cells (2005-2015) [J].
Couto, Pedro S. ;
Bersenev, Alexey ;
Verter, Frances .
REGENERATIVE MEDICINE, 2017, 12 (08) :953-968
[8]   Concise Review: Wharton's Jelly: The Rich, but Enigmatic, Source of Mesenchymal Stromal Cells [J].
Davies, John E. ;
Walker, John T. ;
Keating, Armand .
STEM CELLS TRANSLATIONAL MEDICINE, 2017, 6 (07) :1620-1630
[9]   Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement [J].
Dominici, M. ;
Le Blanc, K. ;
Mueller, I. ;
Slaper-Cortenbach, I. ;
Marini, F. C. ;
Krause, D. S. ;
Deans, R. J. ;
Keating, A. ;
Prockop, D. J. ;
Horwitz, E. M. .
CYTOTHERAPY, 2006, 8 (04) :315-317
[10]   Responsible Translation of Stem Cell Research: An Assessment of Clinical Trial Registration and Publications [J].
Fung, Moses ;
Yuan, Yan ;
Atkins, Harold ;
Shi, Qian ;
Bubela, Tania .
STEM CELL REPORTS, 2017, 8 (05) :1190-1201
123