ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana (Other)

Overall Status

Terminated

CT.gov ID

NCT02579993

Collaborator

National Council of Science and Technology, Mexico (Other)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Limbal Stem Cell Deficiency	Procedure: Pannus and conjunctival dissection Procedure: Human cultivated limbal stem cell transplantation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation Expanded in Vitro on Amniotic Membrane in Patients With Limbal Stem Cell Deficiency.

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stem Cell Transplantation Cultivated Limbal Stem Cell Transplantation	Procedure: Pannus 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. Procedure: Human 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.

Arm

Intervention/Treatment

Experimental: Stem Cell Transplantation

Cultivated Limbal Stem Cell Transplantation

Procedure: Pannus 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.

Procedure: Human 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.

Outcome Measures

Primary Outcome Measures

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.
Objective clinical evaluation [12 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 Outcome Measures

Corneal cells morphology [6 months]
Evaluation of the presence of epithelial, conjunctival or mixed cells with in vivo confocal microscopy and impression cytology
Corneal cells morphology [12 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
Quality of life questionnaire [12 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
Visual acuity [12 months]
Visual acuity in the Logarithm of the Minimum Angle of Resolution scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Bilateral limbal stem cell deficiency of any etiology.
Corneal impression cytology positive for goblet cells.
Ocular ultrasound results within normal parameters.
Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

Active immunological diseases.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto de Oftalmologia Conde de Valenciana	Mexico City		Mexico	06800

Sponsors and Collaborators

Instituto de Oftalmología Fundación Conde de Valenciana
National Council of Science and Technology, Mexico

Investigators

Study Director: Yonathan Garfias, MD, PhD, Instituto de Oftalmologia Conde de Valenciana

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Instituto de Oftalmología Fundación Conde de Valenciana

ClinicalTrials.gov Identifier:

NCT02579993

Other Study ID Numbers:

CI-051-2014

First Posted:

Oct 20, 2015

Last Update Posted:

Mar 6, 2018

Last Verified:

Mar 1, 2018

Keywords provided by Instituto de Oftalmología Fundación Conde de Valenciana

Cornea

Limbal stem cell

Study Results

No Results Posted as of Mar 6, 2018