A randomized, prospective, placebo-controlled feasibility study of systemic administration of equine peripheral blood-derived mesenchymal stem cells in feline chronic kidney disease

Feline chronic kidney disease (CKD) is one of the most frequently diagnosed diseases in cats and affects particular older cats. Regenerative therapies are being explored as a potential solution since current treatments largely address symptoms and disease management without targeting underlying tissue repair. The current study preliminary investigates potential adverse events and the feasibility of a systemic application of primed ( n = 7) or unprimed ( n = 7) equine peripheral blood-derived mesenchymal stem cells (ePB-MSCs) versus placebo control ( n = 7). An exploratory, blinded, randomized placebo-controlled study in 21 cats with feline CKD was performed in one veterinary practice with daily owner evaluations and veterinary visits on days 0, 28 ± 3, 56 ± 3, and 84 ± 3 (optional: days 182 ± 7, 365 ± 14, and 547 ± 14). Three serious adverse events were observed throughout the study period: two in the placebo control product (CP) group and one in the primed ePB-MSC group. Generally, it can be concluded that acceptable adverse events were identified in this small cohort after a single intravenous (IV) administration of primed or unprimed ePB-MSCs in cats with CKD. The blood pressure (BP) change from baseline showed no significant treatment effect ( p = 0.1543). The lowest (unadjusted) p -value ( p = 0.027) was found for the comparison between CP and primed ePB-MSCs at day 56 but failed to be significant as the adjusted comparison-wise significance level equaled p = 0.006. For SDMA ( p = 0.9197), quality of life (QOL) ( p = 0.9742), and IRIS stage ( p = 0.8230), no significant treatment effects were found. In conclusion, the single IV application of ePB-MSCs in cats suffering from CKD showed acceptable adverse events in this small sample size. Based on the current data, there was no evidence that the administration of ePB-MSCs was more effective than the control. Further studies evaluating the efficacy and study limitations of ePB-MSCs in cats suffering from CKD are recommended.