NCT02568527

Biodegradable Synthetic Scaffold as a Substitute for hAM in Limbal Epithelial Cells Transplant in LSCD Patients

Study to Evaluate Safety & Efficacy of PLGA Scaffold to Regenerate Limbal Epithelial Cells Using Autologous Limbal Grafts by SLET (Simple Limbal Epithelial Transplant) Procedure in Patients Having Total Unilateral LSCD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Virender S Sangwan, MBBS, MS · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to undertake a pilot safety and efficacy study of a synthetic biodegradable membrane as a substitute for using donor human amniotic membrane (hAM) for the treatment of limbal stem cell deficiency (LSCD) by combining this with freshly excised limbal tissue in theatre as a one stage procedure

Detailed description

This study will involve the used of a synthetic biodegradable Poly Lactide-co-Glycolic Acid (PLGA) biodegradable, synthetic carrier membrane (PLGA) membrane as a substitute for using donor human amniotic membrane (hAM) for the treatment of limbal stem cell deficiency (LSCD) by combining this with freshly excised limbal tissue in theatre as a one stage procedure. This has the potential to simplify the current procedure and make it safer and accessible to more surgeons and eventually benefit more patients. The use of PLGA membrane, in place of hAM for limbal transplants, is a novel technique and has a lot of promise and potential, which will potentially benefit patients at large and significantly bring down costs for the limbal transplants while reducing the disease transmission risks of using human donor tissue.

Conditions

• Limbal Stem Cell Deficiency

Interventions

Type	Name	Description
DEVICE	PLGA scaffold	Poly-Lactic-co-Glycolic Acid (50:50) biodegradable, synthetic scaffold

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-10-01
• Completion: 2018-07-01
• First posted: 2015-10-06
• Last updated: 2018-08-09

Locations

1 site across 1 country: India