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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)

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ClinicalTrials.gov Identifier: NCT01470573
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : December 10, 2012
Sponsor:
Information provided by (Responsible Party):
Sara Varea, 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.

Condition or disease Intervention/treatment Phase
Unilateral Limbic Insufficiency Procedure: biological replacement corneal surface Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Study Start Date : November 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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




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


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

  2. lack of scar tissue in ocular surface [ Time Frame: 6 months ]
  3. decrease of preexisting corneal vascularization [ Time Frame: 6 months ]
  4. Improvement of corneal transparency [ Time Frame: 6 months ]
  5. 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. adverse events [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 Posted: November 11, 2011    Key Record Dates
Last Update Posted: December 10, 2012
Last Verified: December 2012