Black Linda, Zacharias Shelly, Hughes Mark, Bautista Rachel, Taechangam Nopmanee, Sand Theodore
Gallant Therapeutics, San Diego, CA, United States.
Front Vet Sci. 2022 Sep 23;9:1011174. doi: 10.3389/fvets.2022.1011174. eCollection 2022.
Canine atopic dermatitis (cAD) is a common allergic skin condition among dogs that may respond to treatment with mesenchymal stromal cells (MSCs). The aim of this pilot study was to evaluate the safety and efficacy of allogeneic uterine tissue-derived MSCs (UMSCs) for the reduction and control of clinical signs associated with cAD. At two sites, seven client-owned dogs with cAD received two doses of approximately 3.6 x 10 UMSCs given intravenously over 30 min, on Day 0 and Day 14, with monthly clinical follow-up until Day 90 and optional owner phone interview on Day 180. Primary outcomes were pruritus and skin lesions. Pruritus was measured by the owner-assessed Pruritus Visual Analog Scale (PVAS), with treatment success defined as a 2-point reduction in PVAS score at any timepoint after treatment. Skin lesions were evaluated by two veterinarians according to the Canine Atopic Dermatitis Extent and Severity Index (CADESI-4). The secondary outcome was safety, which was evaluated physical exam and hematology, including complete blood count (CBC), serum chemistry, and urinalysis (UA). Treatment was generally well tolerated and associated with a significant reduction in PVAS on Day 30 that was maintained through Day 180. On Day 60, five dogs (71%) achieved treatment success (at least 2-point reduction in PVAS), and three dogs (43%) had a PVAS improvement of 4-5 points. Mean CADESI-4 score was significantly improved on Day 14, Day 30, Day 60, and Day 90, with the lowest mean score observed on Day 60. Three dogs exhibited mild and transient adverse events. These findings suggest that IV-administered allogeneic UMSCs reduce and control clinical signs of cAD, with a durable benefit lasting 3-6 months.
犬特应性皮炎（cAD）是犬类常见的过敏性皮肤病，间充质基质细胞（MSCs）治疗可能有效。本初步研究的目的是评估同种异体子宫组织来源的间充质基质细胞（UMSCs）减少和控制与cAD相关临床症状的安全性和有效性。在两个地点，7只患有cAD的客户自养犬在第0天和第14天静脉注射两剂约3.6×10的UMSCs，30分钟内注射完毕，每月进行临床随访直至第90天，并在第180天进行可选的主人电话访谈。主要结局指标为瘙痒和皮肤病变。瘙痒通过主人评估的瘙痒视觉模拟量表（PVAS）进行测量，治疗成功定义为治疗后任何时间点PVAS评分降低2分。两名兽医根据犬特应性皮炎范围和严重程度指数（CADESI-4）对皮肤病变进行评估。次要结局指标为安全性，通过体格检查和血液学检查进行评估，包括全血细胞计数（CBC）、血清化学分析和尿液分析（UA）。治疗总体耐受性良好，第30天时PVAS显著降低，并持续至第180天。第60天时，5只犬（71%）治疗成功（PVAS至少降低2分），3只犬（43%）PVAS改善4 - 5分。第14天、第30天、第60天和第90天时，平均CADESI-4评分显著改善，第60天时平均评分最低。3只犬出现轻度短暂不良事件。这些发现表明，静脉注射同种异体UMSCs可减少和控制cAD的临床症状，具有持续3至6个月的持久疗效。
