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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:
ClinicalTrials.gov Identifier:
NCT01470573
First Posted: November 11, 2011
Last Update Posted: December 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sara Varea, Fundacion Clinic per a la Recerca Biomédica
  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: Intervention Model: Single Group Assignment
Masking: None (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 Sara Varea, Fundacion Clinic per a la Recerca Biomédica:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: 6 months ]
    visual acuity improvement


Secondary Outcome Measures:
  • Improvement in appearance of ocular surface [ Time Frame: 6 months ]
    presence of corneal epithelium de novo

  • 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 [ Time Frame: 6 months ]
    the amount of caliciform cells using impression cytology will be compare between screening and 6 months visit

  • adverse events [ Time Frame: 6 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470573


Locations
Spain
Instituto Universitario Barraquer
Barcelona, Spain, 08021
Instituto de Microcirugía Ocular
Barcelona, Spain, 08035
Hospital Clinic of Barcelona
Barcelona, Spain, 08036
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

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
First Submitted: November 9, 2011
First Posted: November 11, 2011
Last Update Posted: December 10, 2012
Last Verified: December 2012