Transplantation of Autologous Oral Mucosal Epithelial Stem Cell Sheet for Treating Limbal Stem Cell Deficiency Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this trials investigates the therapeutic effects of application autologous oral mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease.

Detailed Description
-----------------
A number of external factors can result in limbal stem cell deficiency(LSCD), causing pain, pathological corneal epithelium regeneration, inflammation reaction and seriously visual loss. For patients with unilaterally damaged eye, transplantation of limbal tissue from the healthy eye can be used in the past years in the risk of inducing limbal stem cell damaged in the healthy eye. While graft of human leukocyte antigen matched allogenic limbal stem cells require immune suppressive medications, it can cause side effects in the body. Over the past 10 years, the clinical trials of application of cultured autologous oral mucosal epithelial cell sheet to treat LSCD have been emerged as a promising strategy in many countries. However, little study has been reported in China. This study investigates the therapeutic effects of application autologous oral mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease in China.

Official Title
-----------------
Transplantation of Autologous Oral Mucosal Epithelial Stem Cell Sheet for Treating Limbal Stem Cell Deficiency Disease

Conditions
-----------------
Limbal Stem Cell Deficiency

Intervention / Treatment
-----------------
* Other: cultured autologous oral mucosal epithelial cell sheet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged>=18 years old Normal intraocular pressure Normal Eyelid No cataract and retinal disease No ulcers and tumor in the mouth Exclusion Criteria: Severe Systemic infection History of acute phase of ocular and oral inflammation History of hyper sensibility or allergy to antibiotics or serum Women who are or may be pregnant Patients with infectious diseases Patients with other complications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>cultured autologous oral mucosal epithelial cell sheet | Other: cultured autologous oral mucosal epithelial cell sheet<br>* a prospective study,Before and after self control<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The area of reepithelialization of corneal epithelium | The preoperative status of the eye will be recorded on the basis of clinical drawings and pre-and post-operative photographs. These pictures will be sent to two corneal experts in order to evaluate the results. Judgement criterion: the results will be tested with a slit lamp: Normal: no epithelial loss; Mild: the area of epithelial loss <1/3; Moderate: the area of epithelial loss >1/3 <2/3; Severe: the area of epithelial loss> 2/3 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of best correct visual acuity |  | one year | 
| Decrease of corneal neovascularization |  | one year |