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Completed

NCT Number: NCT01470573

Regenerative Medicine in Ocular Surface: Application of Cell Therapy for Ocular Surface Repair Using Progenitor 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.

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Key information

Conditions

Unilateral Limbic Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Clinic of Barcelona, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biological replacement corneal surface

Procedure

the expanded tissue will be applied to patient to replace the damaged ocular surface

Primary outcomes

  1. Visual Acuity

    Time frame: 6 months

    visual acuity improvement

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica

Other

Registry information

Official study title

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

Acronym: MeRSO09

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 11, 2011
Registry last updated
Dec 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.