Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency

NCT00845117 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2013-06-20

No results posted yet for this study

Summary

The purpose of this study is to determine whether cultivated stem cell transplantation is effective for the treatment of patients wtih corneal stem cell deficiency.

Conditions

  • Limbal Stem Cell Deficiency

Interventions

PROCEDURE

Cultivated limbal stem cell graft transplantation

A limbal biopsy taken from the contralateral good eye in cases of unilateral disease or from a living related or cadaveric donor in cases of bilateral disease. The limbal stem cells from the biopsy are cultivated until a sheet of cells measuring approximately 12mm in diameter is obtained. This is then ready for transplantation onto the diseased eye.

Sponsors & Collaborators

  • Fund for Scientific Research, Flanders, Belgium

    collaborator OTHER
  • European Society of Cataract and Refractive Surgeons

    collaborator OTHER
  • Agentschap voor Innovatie door Wetenschap en Technologie

    collaborator OTHER
  • Ethisch Comité UZ Antwerpen

    lead OTHER

Principal Investigators

  • Nadia Zakaria, MBBS, PhD · University Hospital, Antwerp

  • Carina Koppen, MD, PhD · University Hospital, Antwerp

  • Marie J Tassignon, MD, PhD · University Hospital, Antwerp

  • Zwi Berneman, MD,PhD · University Hospital, Antwerp

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00845117 on ClinicalTrials.gov