SAFETY PROFILE OF SUBRETINAL INJECTION OF HUMAN AMNIOTIC MEMBRANE UMBILICAL CORD PARTICULATE IN PIGS

Abstract

Purpose : To evaluate the safety of a particulate human amniotic membrane/umbilical cord tissue product (AMUC) after subretinal injection in pigs.

Methods : Three groups of two animals each were formed: Vitrectomy and posterior subretinal injection of AMUC (group 1), subretinal injection of BSS as controls (group 2), and subretinal injection of AMUC with no previous vitrectomy (group 3). The follow-up time was one month. We performed physical and ophthalmological examinations at baseline and weekly, electroretinograms at baseline and end of follow-up, and histopathological analysis at end of follow-up. Basal amplitude (AMP) and implicit time (IT) ERG measurements were recorded using the veterinary BMP-200 system (RetinoGraphics, Inc. Norwalk, CT, USA). Differences in ERG were assessed using the paired samples t-test and Wilcoxon matched-pairs signed-ranks test.

Results : There were no apparent toxic effects in any subject. There was only a statistically significant change between basal and final amplitude values in the group receiving subretinal AMUC + vitrectomy, attributed to the surgical procedure.

Conclusions : Subretinal injection of AMUC doesn’t show clinical, histological, or electroretinographic signs of retinal toxicity in pigs. Additional studies should be performed to address AMUC as a therapeutic strategy for retinal disorders.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

 

Figure 1. Representative histopathological specimens stained with hematoxylin & eosin under light microscopy (10X). A: pig #2, group 1 - vitrectomy + subretinal AMUC powder, B: pig #4, group 2- subretinal BSS, C: pig #5, group 3 - subretinal AMUC powder, black arrow highlights bands of suspected AMUC powder.

 

Table 1. ERG Measurements of pre- and post-surgical AMP and IT of pigs