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

Phase 2

Completed

• Conditions: Unilateral Limbic Insufficiency
• Interventions: Procedure: biological replacement corneal surface

• Registration Number: NCT01470573
• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-11
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-07
• Last Update Posted: 2012-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Progenitor Autologous Cells	biological replacement corneal surface	Progenitor Autologous Cells of Sclerocorneal Limbus Amplified ex Vivo

Primary Outcome Measures

Name	Time	Method
Visual Acuity	6 months	visual acuity improvement

Secondary Outcome Measures

Name	Time	Method
Improvement in appearance of ocular surface	6 months	presence of corneal epithelium de novo
lack of scar tissue in ocular surface	6 months
decrease of preexisting corneal vascularization	6 months
Improvement of corneal transparency	6 months
absence or decrease of corneal conjunctivalization	6 months	the amount of caliciform cells using impression cytology will be compare between screening and 6 months visit
adverse events	6 months

Trial Locations

Locations (3)

Instituto de Microcirugía Ocular; 🇪🇸 Barcelona, Spain

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Spain

Instituto Universitario Barraquer; 🇪🇸 Barcelona, Spain