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NCT01942421 Clinical Trial

Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation

Ocular Surface Disease Clinical Trial

Official title:
Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01942421
Other study ID # 639/2551(EC2)
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received December 6, 2011
Last updated September 10, 2013
Start date January 2008
Est. completion date December 2013

Study information
Verified date September 2013
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 20
Est. completion date December 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Cultivated mucosal epithelial transplantation
cultivated autologous mucosal epithelium, then transplant to limbal stem cell deficiency patients.

Locations
Country Name City State
Thailand Pinnita Prabhasawat, MD Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ocular surface clinical and pathological status(signs of limbal deficiency and immunopathological markers)after the surgery Three years Yes
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