Regenerative Medicine in Ocular Surface: Application of Cell Therapy for Ocular Surface Repair Using Progenitor Cells of Sclerocorneal Limbus Amplified ex Vivo (MeRSO09)

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

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 Overview

• Status: Completed
• Conditions: Unilateral Limbic Insufficiency
• Intervention / Treatment: Procedure: biological replacement corneal surface

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic of Barcelona
  • Barcelona, Spain, 08035
    • Instituto de microcirugía ocular
  • Barcelona, Spain, 08021
    • Instituto Universitario Barraquer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Progenitor Autologous Cells; Progenitor Autologous Cells of Sclerocorneal Limbus Amplified ex Vivo	Procedure: biological replacement corneal surface; the expanded tissue will be applied to patient to replace the damaged ocular surface

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	visual acuity improvement	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events		6 months
Improvement in appearance of ocular surface	presence of corneal epithelium de novo	6 months
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	the amount of caliciform cells using impression cytology will be compare between screening and 6 months visit	6 months

Collaborators and Investigators

• Sponsor: Fundacion Clinic per a la Recerca Biomédica
• Investigators: Principal Investigator: Ricardo P Casaroli Marano, MD PhD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: November 9, 2011
• First Submitted That Met QC Criteria: November 10, 2011
• First Posted (Estimate): November 11, 2011

Study Record Updates

• Last Update Posted (Estimate): December 10, 2012
• Last Update Submitted That Met QC Criteria: December 7, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: MeRSO09