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OpenTrials
Completed

NCT Number: NCT01237600

Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction

The purpose of this study is to elucidate the appropriate condition of developing cultivated corneal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated corneal epithelial stem cell in the patients.

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Key information

Conditions

Severe Ocular Surface Damage Limbal Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Pinnita Prabhasawat, MD

Bangkok, 10300, Thailand

About this study

Ocular surface damage caused by severe ocular surface diseases, particularly thermal and chemical burn or Stevens-Johnson syndrome result in corneal epithelial defect, corneal vascularization, corneal conjunctivalization and loss of transparency. Corneal limbal stem cell transplantation has been demonstrated to improve the outcome of ocular surface reconstruction. However, the conventional management of allograft limbal transplantation generally has unsatisfactory outcome because of high risk of rejection and requires long-life immunosuppressive medications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unilateral/Bilateral limbal stem cell deficiency proved by specific clinical features and impression cytology result

Exclusion criteria

  • Age under 18
  • Active ocular infection, Severe dry eye, Uncontrolled glaucoma
  • Immunocompromised host
  • Pregnancy

Treatment and study plan

Cultivated limbal transplantation

Procedure

Cultivated corneal epithelial stem cell transplantation. Autograft, Living related allograft, and Cadaveric allograft

Primary outcomes

  1. Ocular surface status (signs of limbal deficiency and immunopathological markers)

    Time frame: Three years

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 9, 2010
Registry last updated
Dec 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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