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Trial record 21 of 6549 for:    stem cell

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

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ClinicalTrials.gov Identifier: NCT02579993
Recruitment Status : Terminated (Preliminar results not favorable)
First Posted : October 20, 2015
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Instituto de Oftalmología Fundación Conde de Valenciana

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 Not Applicable

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  (Clinical Trial)
Actual Enrollment : 10 participants
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 : March 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

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.



Primary Outcome Measures :
  1. Objective clinical evaluation [ Time Frame: 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.

  2. Objective clinical evaluation [ Time Frame: 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 :
  1. Corneal cells morphology [ Time Frame: 6 months ]
    Evaluation of the presence of epithelial, conjunctival or mixed cells with in vivo confocal microscopy and impression cytology

  2. Corneal cells morphology [ Time Frame: 12 months ]
    Evaluation of the presence of epithelial, conjunctival or mixed cells with in vivo confocal microscopy and impression cytology

  3. Quality of life questionnaire [ Time Frame: 6 months ]
    Modified National Eye Institute Visual Function Questionnaire 25 questionnaire

  4. Quality of life questionnaire [ Time Frame: 12 months ]
    Modified National Eye Institute Visual Function Questionnaire 25 questionnaire

  5. Visual acuity [ Time Frame: 6 months ]
    Visual acuity in the Logarithm of the Minimum Angle of Resolution scale

  6. Visual acuity [ Time Frame: 12 months ]
    Visual acuity in the Logarithm of the Minimum Angle of Resolution scale



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579993


Locations
Mexico
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

Responsible Party: Instituto de Oftalmología Fundación Conde de Valenciana
ClinicalTrials.gov Identifier: NCT02579993     History of Changes
Other Study ID Numbers: CI-051-2014
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

Keywords provided by Instituto de Oftalmología Fundación Conde de Valenciana:
Cornea
Limbal stem cell