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Synthetic biodegradable alternatives to the use of the amniotic membrane for corneal regeneration: assessment of local and systemic toxicity in rabbits
  1. Charanya Ramachandran1,
  2. Virender S Sangwan1,
  3. Ilida Ortega2,
  4. Upendra Bhatnagar3,
  5. Sadik Mohmad Abdulhamid Mulla3,
  6. Rob McKean4,
  7. Sheila MacNeil5
  1. 1 Sudhakar and Sreekanth Ravi Stem Cell Laboratory, LV Prasad Eye Institute, Kallam Anji Reddy campus, LV Prasad Marg, Hyderabad, Telangana, India
  2. 2 School of Clinical Dentistry, Claremont Crescent, University of Sheffield, Sheffield, UK
  3. 3 Preclinical Division, Vimta Labs Ltd, Hyderabad, Telangana, India
  4. 4 The Electrospinning Company Ltd, Rutherford Appleton Laboratory, Oxford, UK
  5. 5 Department of Materials Science and Engineering, Kroto Research Institute, North Campus, University of Sheffield, Sheffield, UK
  1. Correspondence to Dr Sheila MacNeil, Department of Materials Science and Engineering, Kroto Research Institute, North Campus, University of Sheffield, Sheffield S3 7HQ, UK; s.macneil{at}sheffield.ac.uk

Abstract

Aim The aim of this study was to assess the local and systemic response to poly-lactic co-glycolic acid (PLGA) 50:50 membranes, developed as synthetic biodegradable alternatives to the use of human donor amniotic membrane in the treatment of limbal stem cell deficiency.

Methods PLGA membranes of 2  cm diameter and 50  µm thickness were placed on one eye of rabbits and secured in place using fibrin glue and a bandage contact lens, suturing the eye close with a single stitch. Control animals were treated identically, with the absence of the membranes. Plain and microfabricated electrospun membranes (containing micropockets which roughly emulate the native limbal niche) were examined over 29 days. All animals were subjected to a detailed gross and histopathological observation as well as a detailed examination of the eye.

Results Application of the membranes both with and without microfabricated pockets did not adversely affect animal welfare. There was complete degradation of the membranes by day 29. The membranes did not induce any significant local or systemic toxicity. Conjunctival congestion and corneal vascularisation were noted in a few control and PLGA-treated animals. Intraocular pressure was normal and the retinal status was unaltered. The ocular surface was clear and intact in all animals by the end of 29  days.

Conclusion Membranes of 50:50 PLGA can be safely applied to rabbit corneas without inducing any local or systemic toxicity and these break down completely within 29 days.

  • cornea
  • ocular surface
  • stem cells

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Footnotes

  • Contributors CR was responsible for the conception of study, data analysis, interpretation of data and manuscript preparation. VSS was involved in the conception of study and interpretation of data. IO was responsible for the design of PLGA materials and manuscript preparation. UB and SM were involved in the design of study, data collection and analysis. RMK contributed to the manuscript preparation. SMN contributed to the conception and design of study, data interpretation and manuscript preparation and approval.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent Not required.

  • Ethics approval Institutional Animal Ethics committee of VIMTA Labs Limited.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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