Regenerative Medicine in Ocular Surface: Application of Cell Therapy for Ocular Surface Repair Using Progenitor Cells of Sclerocorneal Limbus Amplified ex Vivo

Fundacion Clinic per a la Recerca Biomédica10 enrolled

Overview

Progenitor limbo sclerocorneal cells have properties of proliferation and differentiation to corneal and conjunctival epithelium. This cells can be isolated and ex vivo expanded using cell culture technics that could permit the biological replacement of damaged ocular surface.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Unilateral Limbic Insufficiency

Interventions

biological replacement corneal surfacePROCEDURE

the expanded tissue will be applied to patient to replace the damaged ocular surface

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

principal Inclusion Criteria: * Serious unilateral limbic insufficiency * Normal ophthalmological clinical examination in the opposite eye (biopsied eye) Exclusion Criteria: * one-eyed * serious disorders in palpebral dynamics * bilateral limbic insufficiency, immunological, systemic or local illness like toxical epidermic necrosis or pemphigoid * breastfeeding or pregnancy * positive serology of HIV, VLTH, HVC, HVB, CMV, Trypanosoma Cruzi or Treponema Pallidum

Locations (3)

Instituto Universitario Barraquer

Barcelona, Barcelona, Spain

Instituto de Microcirugía Ocular

Barcelona, Barcelona, Spain

Hospital Clinic of Barcelona

Barcelona, Barcelona, Spain

Outcomes

Primary Outcomes

Visual Acuity

visual acuity improvement

Time frame: 6 months

Secondary Outcomes

Improvement in appearance of ocular surface

presence of corneal epithelium de novo

Time frame: 6 months

lack of scar tissue in ocular surface

Time frame: 6 months

decrease of preexisting corneal vascularization

Time frame: 6 months

Improvement of corneal transparency

Time frame: 6 months

absence or decrease of corneal conjunctivalization

the amount of caliciform cells using impression cytology will be compare between screening and 6 months visit

Time frame: 6 months

adverse events

Time frame: 6 months

Data from ClinicalTrials.gov

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