Limbal Stem Cell Deficiency
Conditions
Keywords
Cornea, Limbal stem cell
Brief summary
In this study the prognostic value of ABCB5 in survival of the limbal stem cell transplantation expanded in vitro on amniotic membrane for corneal surface reconstruction in patients with limbal stem cell deficiency will be analyzed.
Detailed description
There are several diseases that cause the cornea to lose its clarity and directly affects the vision of the individual, therefore, the use of limbal stem cells has been having increasing acceptance in the field of medical therapy. An open clinical study is running with patients with limbal stem cell deficiency, performing a limbal stem cell transplantation expanded in vitro on amniotic membrane and the value of ABCB5 as a prognostic factor in the survival of transplant will be determined. The corneal surface status will be the primary endpoint.
Interventions
PROCEDUREPannus and conjunctival dissection
A complete conjunctival peritomy is performed and the fibrovascular pannus and conjunctiva invading the cornea is dissected from the cornea and limbus.
PROCEDUREHuman cultivated limbal stem cell transplantation
The amniotic membrane graft cultured with the human limbal stem cell transplantation is placed in the limbic and corneal surface and fixed with fibrin glue. The amniotic membrane is placed with the stroma in contact with the graft and it is sutured.
Sponsors
National Council of Science and Technology, Mexico
Instituto de Oftalmología Fundación Conde de Valenciana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Bilateral limbal stem cell deficiency of any etiology. 2. Corneal impression cytology positive for goblet cells. 3. Ocular ultrasound results within normal parameters. 4. Agree to participate in the study and sign the informed consent.
Exclusion criteria
1\. Active immunological diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective clinical evaluation | 6 months | A grading system from 0 to 4 using photographs taken with slit lamp, will be used to determine by two independent examiners the degree of corneal transparency and superficial vascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corneal cells morphology | 6 months | Evaluation of the presence of epithelial, conjunctival or mixed cells with in vivo confocal microscopy and impression cytology |
| Quality of life questionnaire | 6 months | Modified National Eye Institute Visual Function Questionnaire 25 questionnaire |
| Visual acuity | 6 months | Visual acuity in the Logarithm of the Minimum Angle of Resolution scale |
Countries
Mexico
Outcome results
None listed