Preprint Article Version 1 This version is not peer-reviewed

In situ treatment of refractory canine perianal fistulas with low-dose allogeneic adipose tissue-derived mesenchymal stem cells

Version 1 : Received: 12 July 2024 / Approved: 12 July 2024 / Online: 15 July 2024 (10:44:28 CEST)

How to cite: Enciso, N.; Enciso-Benavides, J.; Sandoval, J.; Enciso, J. In situ treatment of refractory canine perianal fistulas with low-dose allogeneic adipose tissue-derived mesenchymal stem cells. Preprints 2024, 2024071027. https://doi.org/10.20944/preprints202407.1027.v1 Enciso, N.; Enciso-Benavides, J.; Sandoval, J.; Enciso, J. In situ treatment of refractory canine perianal fistulas with low-dose allogeneic adipose tissue-derived mesenchymal stem cells. Preprints 2024, 2024071027. https://doi.org/10.20944/preprints202407.1027.v1

Abstract

Stem cell therapy in canines has increased considerably in recent years; however, there are few publications on the treatment of perianal fistulas (PF) in this species, and there is no agreed protocol for the number of cells per dose and their repetitions, nor for the in situ delivery methodology and follow-up period after cell therapy. The aim of this open-label clinical trial was to demonstrate the efficacy and safety of a new protocol for in situ administration of low-dose, expanded and cryopreserved allogeneic adipose-derived stem cells for the treatment of refractory spontaneous perianal fistula. The methodology consisted of intralesional application of 1 to 3 doses - depending on evidence of clinical signs of recurrence - of 5x106 cryopreserved allogeneic adipose-derived allogeneic stem cells in each fistula. The study was conducted in 14 dogs regardless of sex, breed or age with a clinical diagnosis of refractory PF presented between January 2019 and December 2023. Cells were diluted in 1 mL of phosphate-buffered saline and this volume was applied to five sites at the edge of the FP in an amount of 1x106 per application site. The evolution of the fistula was followed for 12 to 48 months. Efficacy was determined by complete healing as evidenced by complete closure of the fistula, which was observed in 100% of the cases studied one month after therapy, with a subsequent follow-up of 12 to 48 months after therapy. In addition, there were no local or systemic adverse effects assessed by clinical examination, complete blood count and blood biochemistry. In conclusion, the protocol used in this work demonstrates the efficacy without adverse effects of in situ application of allogeneic adipose-derived adipose stem cells in low doses and cell replicates to treat canine refractory PF, providing a simple, non-invasive, long-lasting and low-cost therapeutic option.

Keywords

Stem cells; cell therapy; canine; perianal fistula

Subject

Biology and Life Sciences, Animal Science, Veterinary Science and Zoology

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