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

Primary Purpose

Limbal Stem Cell Deficiency

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
cultured autologous oral mucosal epithelial cell sheet
Sponsored by
He Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Limbal Stem Cell Deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    experimental group

    Arm Description

    cultured autologous oral mucosal epithelial cell sheet

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Improvement of best correct visual acuity
    Decrease of corneal neovascularization

    Full Information

    First Posted
    January 5, 2017
    Last Updated
    January 8, 2017
    Sponsor
    He Eye Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03015779
    Brief Title
    Transplantation of Autologous Oral Mucosal Epithelial Stem Cell Sheet for Treating Limbal Stem Cell Deficiency Disease
    Official Title
    Transplantation of Autologous Oral Mucosal Epithelial Stem Cell Sheet for Treating Limbal Stem Cell Deficiency Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    He Eye Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Limbal Stem Cell Deficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    7 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    cultured autologous oral mucosal epithelial cell sheet
    Intervention Type
    Other
    Intervention Name(s)
    cultured autologous oral mucosal epithelial cell sheet
    Intervention Description
    a prospective study,Before and after self control
    Primary Outcome Measure Information:
    Title
    The area of reepithelialization of corneal epithelium
    Description
    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
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Improvement of best correct visual acuity
    Time Frame
    one year
    Title
    Decrease of corneal neovascularization
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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