Intra-uterine injection of amnion-derived acellular bioscaffold product in mares, a description of systemic and intra-uterine effects over 21 days.

Overview

• This study investigates the safety of injecting an amnion-derived acellular bioscaffold product (ADABP) into the uterus of mares and examines any systemic and intrauterine effects over a 21-day period.
• The research focuses on whether the ADABP, known for its anti-inflammatory and healing properties, causes any adverse effects when administered intrauterinely.

Background and Purpose

• Amnion-derived acellular bioscaffold products (ADABP) are materials derived from the amniotic membrane, processed to remove cellular components while preserving structural and biochemical properties.
• These products have demonstrated anti-inflammatory effects and promote healing in various tissues, leading to interest in their potential use in reproductive medicine, particularly for treating uterine conditions in mares.
• The study sought to determine if injecting ADABP directly into the uterine horns of mares would be safe, meaning it would not provoke harmful systemic or local effects.

Study Design

• The experiment involved twelve mares divided into two groups:
  • Control group (n=3): mares receiving injections of sterile saline (3 mL) into the base of each uterine horn.
  • Treatment group (n=9): mares receiving 3 mL of ADABP injected into one uterine horn and 3 mL sterile saline injected in the contralateral horn.
• This within-subject design in the treatment group allows direct comparison between ADABP-injected and saline-injected uterine horns in the same animal.
• The mares were monitored for 21 days post-injection to observe both systemic and local uterine effects.

Measurements and Observations

• Systemic health was evaluated through:
  • Leukogram (white blood cell count and differential), an indicator of systemic inflammation or infection.
  • Serum biochemistry panel to assess organ function and metabolic status.
• Local uterine health was assessed by:
  • Uterine culture to check for bacterial contamination or infection.
  • Uterine biopsy to examine tissue histology for signs of inflammation, tissue damage, or abnormal healing responses.

Key Findings

• Leukogram results showed no significant differences between groups or over time, indicating no systemic inflammatory response triggered by ADABP injection.
• Serum biochemistry parameters remained unaffected by treatment, suggesting no adverse systemic effects on liver, kidney, or metabolic function.
• Uterine cultures were similar between ADABP and saline-injected horns, with no increased presence of pathogenic bacteria associated with the bioscaffold.
• Uterine biopsies revealed no meaningful histological differences or evidence of negative tissue reactions between the treated and control horns.

Conclusions and Implications

• The data from this study suggest that intrauterine injection of ADABP in mares is safe, causing no harmful local or systemic effects during the three-week monitoring period.
• This finding supports the potential use of ADABP as a therapeutic agent within the uterus, possibly to aid in healing or reduce inflammation without provoking adverse immune or pathological responses.
• Future studies may build on this safety data to explore the efficacy of ADABP in treating uterine diseases or improving fertility outcomes in mares.