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

NCT02568527 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2018-08-09

No results posted yet for this study

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

Conditions

  • Limbal Stem Cell Deficiency

Interventions

DEVICE

PLGA scaffold

Poly-Lactic-co-Glycolic Acid (50:50) biodegradable, synthetic scaffold

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • University of Sheffield

    collaborator OTHER

  • Virender S Sangwan, MBBS, MS

    lead OTHER

Principal Investigators

  • Virender S Sangwan, MBBS MS · LV Prasad Eye Institute

  • Sayan Basu, MBBS MS · LV Prasad Eye Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-10-31
Completion
2018-07-31

Countries

  • India

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02568527 on ClinicalTrials.gov