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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

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 Summary: 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.
Sponsor: He Eye Hospital

Current Primary Outcome: The area of reepithelialization of corneal epithelium [ Time Frame: 3 months ]

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



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Improvement of best correct visual acuity [ Time Frame: one year ]
  • Decrease of corneal neovascularization [ Time Frame: one year ]


Original Secondary Outcome: Same as current

Information By: He Eye Hospital

Dates:
Date Received: January 5, 2017
Date Started: January 2017
Date Completion: December 2018
Last Updated: January 8, 2017
Last Verified: January 2017