Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction

Mahidol University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Limbal Deficiency; Severe Ocular Surface Damage

Treatments: Procedure: Cultivated limbal transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01237600

447/2550(EC2)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

19 participants in 1 patient group

Cultivated limbal transplantation

Experimental group

Treatment:

Procedure: Cultivated limbal transplantation