Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation

• Sponsor: Mahidol University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01942421
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 71
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Surface Disease	Procedure: Cultivated mucosal epithelial transplantation	Phase 2/Phase 3

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation.
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Jun 1, 2013
• Anticipated Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cultivated mucosal epithelial transplant Cultivated mucosal epithelial transplantaion to limbal deficiency patients	Procedure: Cultivated mucosal epithelial transplantation; cultivated autologous mucosal epithelium, then transplant to limbal stem cell deficiency patients.

Outcome Measures

Primary Outcome Measures

1. Ocular surface clinical and pathological status(signs of limbal deficiency and immunopathological markers)after the surgery [Three years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pinnita Prabhasawat, MD	Bangkok		Thailand	10300

Sponsors and Collaborators

• Mahidol University

Investigators

• Principal Investigator: Pinnita Prabhasawat, MD, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pinnita Prabhasawat, Associate professor, Mahidol University
• ClinicalTrials.gov Identifier: NCT01942421
• Other Study ID Numbers: 639/2551(EC2)
• First Posted: Sep 16, 2013
• Last Update Posted: Sep 16, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by Pinnita Prabhasawat, Associate professor, Mahidol University: Limbal deficiency; Cultivated limbal transplantation; Ex vivo limbal transplantation; Cultivated autologous mucosal epithelial transplantation

Study Results

No Results Posted as of Sep 16, 2013