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Equine allogeneic chondrogenic induced mesenchymal stem cells : a GCP target animal safety and biodistribution study

SY Broeckx, JH Spaas, Koen Chiers (UGent) , Luc Duchateau (UGent) , Lore Van Hecke (UGent) , Leen Van Brantegem (UGent) , Michèle Dumoulin (UGent) , Ann Martens (UGent) and Frederik Pille (UGent)
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Abstract
The safety of the intra-articular use of mesenchymal stem cells (MSCs) is scarcely reported. Therefore, the goal of this study was to investigate the safety of a single intra-articular injection with allogeneic chondrogenic induced MSCs combined with equine plasma (= the investigational product: IVP) compared to a saline (0.9% NaCl) placebo control (= control product: CP). Sixteen healthy experimental horses were randomly assigned to receive a single intra-articular injection with either the IVP (n = 8) or the CP (n = 8) in the left metacarpophalangeal joint. All horses underwent a daily clinical assessment throughout the entire study period of 42 days to assess adverse events. Additionally, a local joint assessment and a lameness examination were performed daily during the first two weeks, and weekly the following 4 weeks. Blood samples were taken weekly for hematological and biochemical analysis. At the end of the study period, horses of the IVP group were euthanized for a thorough necropsy and to check for biodistribution. Tissue samples of the injected joint were collected for histological examination. In both CP and IVP treated horses a mild transient subjective increase in periarticular temperature and lameness was noted after the intra-articular injection with no significant differences between the treatment groups. No distribution of the cells was found using immunohistochemistry and no ectopic tissue formation or signs of inflammation were found on histology. A single intra-articular injection of allogeneic chondrogenic induced MSCs combined with allogeneic plasma in horses had the same clinical side effects as an intra-articular injection with saline solution.
Keywords
Allogeneic, Chrondrogenic induced, Mesenchymal stem cells, Osteoarthritis, Plasma, Safety, DEGENERATIVE JOINT DISEASE, PERIPHERAL-BLOOD, INTRAARTICULAR INJECTION, STROMAL CELLS, MODEL, OSTEOARTHRITIS, HORSES, DEFECTS, MARKER, INJURY

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Chicago
Broeckx, SY, JH Spaas, Koen Chiers, Luc Duchateau, Lore Van Hecke, Leen Van Brantegem, Michèle Dumoulin, Ann Martens, and Frederik Pille. 2018. “Equine Allogeneic Chondrogenic Induced Mesenchymal Stem Cells : a GCP Target Animal Safety and Biodistribution Study.” Research in Veterinary Science 117: 246–254.
APA
Broeckx, SY, Spaas, J., Chiers, K., Duchateau, L., Van Hecke, L., Van Brantegem, L., Dumoulin, M., et al. (2018). Equine allogeneic chondrogenic induced mesenchymal stem cells : a GCP target animal safety and biodistribution study. RESEARCH IN VETERINARY SCIENCE, 117, 246–254.
Vancouver
1.
Broeckx S, Spaas J, Chiers K, Duchateau L, Van Hecke L, Van Brantegem L, et al. Equine allogeneic chondrogenic induced mesenchymal stem cells : a GCP target animal safety and biodistribution study. RESEARCH IN VETERINARY SCIENCE. 2018;117:246–54.
MLA
Broeckx, SY, JH Spaas, Koen Chiers, et al. “Equine Allogeneic Chondrogenic Induced Mesenchymal Stem Cells : a GCP Target Animal Safety and Biodistribution Study.” RESEARCH IN VETERINARY SCIENCE 117 (2018): 246–254. Print.
@article{8549503,
  abstract     = {The safety of the intra-articular use of mesenchymal stem cells (MSCs) is scarcely reported. Therefore, the goal of this study was to investigate the safety of a single intra-articular injection with allogeneic chondrogenic induced MSCs combined with equine plasma (= the investigational product: IVP) compared to a saline (0.9\% NaCl) placebo control (= control product: CP). Sixteen healthy experimental horses were randomly assigned to receive a single intra-articular injection with either the IVP (n = 8) or the CP (n = 8) in the left metacarpophalangeal joint. All horses underwent a daily clinical assessment throughout the entire study period of 42 days to assess adverse events. Additionally, a local joint assessment and a lameness examination were performed daily during the first two weeks, and weekly the following 4 weeks. Blood samples were taken weekly for hematological and biochemical analysis. At the end of the study period, horses of the IVP group were euthanized for a thorough necropsy and to check for biodistribution. Tissue samples of the injected joint were collected for histological examination. In both CP and IVP treated horses a mild transient subjective increase in periarticular temperature and lameness was noted after the intra-articular injection with no significant differences between the treatment groups. No distribution of the cells was found using immunohistochemistry and no ectopic tissue formation or signs of inflammation were found on histology. A single intra-articular injection of allogeneic chondrogenic induced MSCs combined with allogeneic plasma in horses had the same clinical side effects as an intra-articular injection with saline solution.},
  author       = {Broeckx, SY and Spaas, JH and Chiers, Koen and Duchateau, Luc and Van Hecke, Lore and Van Brantegem, Leen and Dumoulin, Mich{\`e}le and Martens, Ann and Pille, Frederik},
  issn         = {0034-5288},
  journal      = {RESEARCH IN VETERINARY SCIENCE},
  keyword      = {Allogeneic,Chrondrogenic induced,Mesenchymal stem cells,Osteoarthritis,Plasma,Safety,DEGENERATIVE JOINT DISEASE,PERIPHERAL-BLOOD,INTRAARTICULAR INJECTION,STROMAL CELLS,MODEL,OSTEOARTHRITIS,HORSES,DEFECTS,MARKER,INJURY},
  language     = {eng},
  pages        = {246--254},
  title        = {Equine allogeneic chondrogenic induced mesenchymal stem cells : a GCP target animal safety and biodistribution study},
  url          = {http://dx.doi.org/10.1016/j.rvsc.2017.12.018},
  volume       = {117},
  year         = {2018},
}

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