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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Limbal Stem Cell Deficiency
• Intervention / Treatment: Procedure: Pannus and conjunctival dissection; Procedure: Human cultivated limbal stem cell transplantation

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 06800
    • Instituto de Oftalmología Conde de Valenciana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
• Collaborators: National Council of Science and Technology, Mexico
• Investigators: Study Director: Yonathan Garfias, MD, PhD, Instituto de Oftalmología Conde de Valenciana

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: October 11, 2015
• First Submitted That Met QC Criteria: October 17, 2015
• First Posted (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Actual): March 6, 2018
• Last Update Submitted That Met QC Criteria: March 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Cornea; Limbal stem cell
• Other Study ID Numbers: CI-051-2014