Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation

Mahidol University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Ocular Surface Disease

Treatments: Procedure: Cultivated mucosal epithelial transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01942421

639/2551(EC2)

Details and patient eligibility

About

The purpose of this study is to elucidate the appropriate condition of developing cultivated autologous oral mucosal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated cells in the patients.

Full description

Ocular surface damage caused by severe ocular surface diseases. 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. Ocular surface reconstruction with cultivated autologous mucosal epithelial transplantation is served to improve the surgical results of ocular surface reconstruction and decrease the use of immunosuppressive medications

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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)

---

20 participants in 1 patient group

Cultivated mucosal epithelial transplant

Experimental group

Description:

Cultivated mucosal epithelial transplantaion to limbal deficiency patients

Treatment:

Procedure: Cultivated mucosal epithelial transplantation