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Clinical Trials/NCT01470573
NCT01470573CompletedPhase 2

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

Fundacion Clinic per a la Recerca Biomédica6 sites in 1 country10 target enrollmentStarted: November 1, 2011Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
10
Locations
6
Primary Endpoint
Visual Acuity
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •principal Inclusion Criteria:
  • •Serious unilateral limbic insufficiency
  • •Normal ophthalmological clinical examination in the opposite eye (biopsied eye)

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Visual Acuity

Time Frame: 6 months

visual acuity improvement

Secondary Outcomes

  • Improvement in appearance of ocular surface(6 months)
  • lack of scar tissue in ocular surface(6 months)
  • decrease of preexisting corneal vascularization(6 months)
  • Improvement of corneal transparency(6 months)
  • absence or decrease of corneal conjunctivalization(6 months)
  • adverse events(6 months)

Investigators

Sponsor
Fundacion Clinic per a la Recerca Biomédica
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sara Varea

Clinical Research Manager

Fundacion Clinic per a la Recerca Biomédica

Study Sites (6)

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