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

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ClinicalTrials.gov Identifier: NCT03015779
Recruitment Status : Unknown
Verified January 2017 by He Eye Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : January 10, 2017
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
He Eye Hospital

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.

Condition or disease Intervention/treatment Phase
Limbal Stem Cell Deficiency Other: cultured autologous oral mucosal epithelial cell sheet Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transplantation of Autologous Oral Mucosal Epithelial Stem Cell Sheet for Treating Limbal Stem Cell Deficiency Disease
Study Start Date : January 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: experimental group
cultured autologous oral mucosal epithelial cell sheet
Other: cultured autologous oral mucosal epithelial cell sheet
a prospective study,Before and after self control




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Improvement of best correct visual acuity [ Time Frame: one year ]
  2. Decrease of corneal neovascularization [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: He Eye Hospital
ClinicalTrials.gov Identifier: NCT03015779    
Other Study ID Numbers: 20161029
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Deficiency Diseases
Malnutrition
Nutrition Disorders