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

Instituto de Oftalmología Fundación Conde de Valenciana

Status: Terminated

Conditions: Limbal Stem Cell Deficiency

Treatments: Procedure: Human cultivated limbal stem cell transplantation; Procedure: Pannus and conjunctival dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT02579993

CI-051-2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Stem Cell Transplantation

Experimental group

Description:

Cultivated Limbal Stem Cell Transplantation

Treatment:

Procedure: Pannus and conjunctival dissection

Procedure: Human cultivated limbal stem cell transplantation