Broeckx S Y, Spaas J H, Chiers K, Duchateau L, Van Hecke L, Van Brantegem L, Dumoulin M, Martens A M, Pille F
Global Stem Cell Technology NV, Anacura Group, Noorwegenstraat 4, 9940 Evergem, Belgium.
Department of Pathology, Bacteriology and Poultry Diseases, Faculty of Veterinary Medicine, Ghent University, Salisburylaan 133, 9820 Merelbeke, Belgium.
Res Vet Sci. 2018 Apr;117:246-254. doi: 10.1016/j.rvsc.2017.12.018. Epub 2017 Dec 27.
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 42days 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 4weeks. 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.
间充质干细胞（MSCs）关节内使用的安全性鲜有报道。因此，本研究的目的是调查与生理盐水（0.9%氯化钠）安慰剂对照（=对照产品：CP）相比，同种异体软骨诱导MSCs与马血浆联合使用（=研究产品：IVP）进行单次关节内注射的安全性。16匹健康实验马被随机分配，在左掌指关节接受单次关节内注射IVP（n = 8）或CP（n = 8）。在整个42天的研究期间，所有马匹每天都接受临床评估以评估不良事件。此外，在最初两周内每天进行局部关节评估和跛行检查，随后四周每周进行一次。每周采集血样进行血液学和生化分析。在研究期结束时，对IVP组的马匹实施安乐死以进行全面尸检并检查生物分布。收集注射关节的组织样本进行组织学检查。在CP和IVP治疗的马匹中，关节内注射后均注意到关节周围温度和跛行有轻微短暂的主观升高，治疗组之间无显著差异。免疫组织化学未发现细胞分布，组织学检查未发现异位组织形成或炎症迹象。在马中，同种异体软骨诱导MSCs与同种异体血浆联合进行单次关节内注射与关节内注射生理盐水溶液具有相同的临床副作用。
