Not provided
Not provided
Not provided
Not provided
Not provided
Preliminar results not favorable
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Council of Science and Technology, Mexico | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem Cell Transplantation | Experimental | Cultivated Limbal Stem Cell Transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pannus and conjunctival dissection | Procedure | A complete conjunctival peritomy is performed and the fibrovascular pannus and conjunctiva invading the cornea is dissected from the cornea and limbus. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective clinical evaluation | 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. | 6 months |
| Objective clinical evaluation | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal cells morphology | Evaluation of the presence of epithelial, conjunctival or mixed cells with in vivo confocal microscopy and impression cytology | 6 months |
| Corneal cells morphology | Evaluation of the presence of epithelial, conjunctival or mixed cells with in vivo confocal microscopy and impression cytology |
Not provided
Inclusion Criteria:
Exclusion Criteria:
1. Active immunological diseases.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yonathan Garfias, MD, PhD | Instituto de Oftalmologia Conde de Valenciana | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Oftalmologia Conde de Valenciana | Mexico City | 06800 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32077779 | Derived | Serna-Ojeda JC, Garcia-Mejia M, Graue-Hernandez EO, Navas A, Garfias Y. Short-Term Results Analysis in the Allogenic Transplantation of Limbal Stem Cells Expanded on Amniotic Membrane in Patients with Bilateral Limbal Stem Cell Deficiency. J Ocul Pharmacol Ther. 2020 May;36(4):238-246. doi: 10.1089/jop.2019.0147. Epub 2020 Feb 20. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000092423 | Limbal Stem Cell Deficiency |
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Human cultivated limbal stem cell transplantation | Procedure | 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. |
|
| 12 months |
| Quality of life questionnaire | Modified National Eye Institute Visual Function Questionnaire 25 questionnaire | 6 months |
| Quality of life questionnaire | Modified National Eye Institute Visual Function Questionnaire 25 questionnaire | 12 months |
| Visual acuity | Visual acuity in the Logarithm of the Minimum Angle of Resolution scale | 6 months |
| Visual acuity | Visual acuity in the Logarithm of the Minimum Angle of Resolution scale | 12 months |