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ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation
资助者: Instituto de Oftalmología Fundación Conde de Valenciana
合作者: National Council of Science and Technology, Mexico
监督者: Study Director: Yonathan Garfias, MD, PhD Instituto de Oftalmologia Conde de Valenciana

预计研究完成时间: 2018-03-01
预计完成时间: 2018-03-01

详细标题

  • 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.

简略摘要

  • 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.

详细摘要

  • 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.

研究层级

  • Interventional

研究阶段

  • Not Applicable

研究设计

  • Intervention Model: Single Group Assignment
    Masking: None (Open Label)
    Primary Purpose: Treatment

研究条件

  • Limbal Stem Cell Deficiency

研究干预

  • 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.

研究手段

  • Experimental: Stem Cell Transplantation Cultivated Limbal Stem Cell Transplantation Interventions: Procedure: Pannus and conjunctival dissection Procedure: Human cultivated limbal stem cell transplantation

出版物


研究状态

  • Terminated

招聘人数

  • 10

招聘准则

  • 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: 1. Active immunological diseases.

性别

  • Sexes Eligible for Study: All

年龄

  • 16 Years and older   (Child, Adult, Older Adult)

志愿者

  • No

联系人

  • Contact information is only displayed when the study is recruiting subjects

国别

  • Mexico

NCT编号

  • NCT02579993