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

NCT ID: NCT02579993

Last Updated: 2018-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-03-31

Brief Summary

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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

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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.

Conditions

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Limbal Stem Cell Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stem Cell Transplantation

Cultivated Limbal Stem Cell Transplantation

Group Type EXPERIMENTAL

Pannus and conjunctival dissection

Intervention Type PROCEDURE

A complete conjunctival peritomy is performed and the fibrovascular pannus and conjunctiva invading the cornea is dissected from the cornea and limbus.

Human cultivated limbal stem cell transplantation

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Council of Science and Technology, Mexico

OTHER

Sponsor Role collaborator

Instituto de Oftalmología Fundación Conde de Valenciana

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yonathan Garfias, MD, PhD

Role: STUDY_DIRECTOR

Instituto de Oftalmologia Conde de Valenciana

Locations

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Instituto de Oftalmologia Conde de Valenciana

Mexico City, , Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type DERIVED
PMID: 32077779 (View on PubMed)

Other Identifiers

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CI-051-2014

Identifier Type: -

Identifier Source: org_study_id

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