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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sara Varea, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier:
NCT01470573
First received: November 9, 2011
Last updated: December 7, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Unilateral Limbic Insufficiency
 Procedure: biological replacement corneal surface
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Regenerative Medicine in Ocular Surface: Application of Cell Therapy for Ocular Surface Repair Using Progenitor Autologous Cells of Sclerocorneal Limbus Amplified ex Vivo

Further study details as provided by Fundacion Clinic per a la Recerca Biomédica:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    visual acuity improvement


Secondary Outcome Measures:
  • Improvement in appearance of ocular surface [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    presence of corneal epithelium de novo

  • lack of scar tissue in ocular surface [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • decrease of preexisting corneal vascularization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Improvement of corneal transparency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • absence or decrease of corneal conjunctivalization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    the amount of caliciform cells using impression cytology will be compare between screening and 6 months visit

  • adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: November 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01470573

Locations
Spain
Hospital Clinic of Barcelona
Barcelona, Spain, 08036
Instituto Universitario Barraquer
Barcelona, Spain, 08021
Instituto de Microcirugía Ocular
Barcelona, Spain, 08035
Sponsors and Collaborators
Fundacion Clinic per a la Recerca Biomédica
Investigators
Principal Investigator: Ricardo P Casaroli Marano, MD PhD Hospital Clinic of Barcelona
  More Information

No publications provided

Responsible Party: Sara Varea, Clinical Research Manager, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT01470573     History of Changes
Other Study ID Numbers: MeRSO09
Study First Received: November 9, 2011
Last Updated: December 7, 2012
Health Authority: Spain: Spanish Agency of Medicines

ClinicalTrials.gov processed this record on May 16, 2013