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

December 7, 2012 updated by: Sara Varea, Fundacion Clinic per a la Recerca Biomédica

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic of Barcelona
      • Barcelona, Spain, 08035
        • Instituto de Microcirugia Ocular
      • Barcelona, Spain, 08021
        • Instituto Universitario Barraquer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 6 months
visual acuity improvement
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Clinic per a la Recerca Biomédica

Investigators

  • Principal Investigator: Ricardo P Casaroli Marano, MD PhD, Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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