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

NCT ID: NCT01470573

Last Updated: 2012-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Unilateral Limbic Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Progenitor Autologous Cells

Progenitor Autologous Cells of Sclerocorneal Limbus Amplified ex Vivo

Group Type EXPERIMENTAL

biological replacement corneal surface

Intervention Type PROCEDURE

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

Interventions

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biological replacement corneal surface

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacion Clinic per a la Recerca Biomédica

OTHER

Sponsor Role lead

Responsible Party

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Sara Varea

Clinical Research Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ricardo P Casaroli Marano, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

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Instituto Universitario Barraquer

Barcelona, Barcelona, Spain

Site Status

Instituto de MicrocirugĂ­a Ocular

Barcelona, Barcelona, Spain

Site Status

Hospital Clinic of Barcelona

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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MeRSO09

Identifier Type: -

Identifier Source: org_study_id