NCT00845117

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 20, 2013

Status Verified

June 1, 2013

Enrollment Period

5.9 years

First QC Date

February 17, 2009

Last Update Submit

June 19, 2013

Conditions

Limbal Stem Cell Deficiency

Keywords

Aniridia,Steven Johnsons Syndrome,Ocular burns,Pterygium

Outcome Measures

Primary Outcomes (4)

  • Visual Acuity

    Just before surgery and upto 1 years after surgery

  • Conjunctivalization

    Just before surgery and upto 1 years after surgery

  • Vascularization

    Just before surgery and upto 1 years after surgery

  • Epithelialization

    Just before surgery and upto 1 years after surgery

Secondary Outcomes (1)

  • Prolonged subsequent corneal graft survival time

    1 year post corneal transplant

Study Arms (1)

Limbal Stem Cell Transplant

EXPERIMENTAL

The cornea is debrided of all superficial fibrovascular tissue and the cultivated stem cell graft is glued onto the cornea.

Procedure: Cultivated limbal stem cell graft transplantation

Interventions

Cultivated limbal stem cell graft transplantationPROCEDURE

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.

Limbal Stem Cell Transplant

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from LSCD IIa and IIb. Those suffering from IIc may be included once inflammation has subsided and cornea can be staged as IIb.
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
  • Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation

You may not qualify if:

  • Subjects who are pregnant or lactating
  • Subjects who have sensitivity to drugs that provide local anesthesia
  • Subjects suffering from active infection of the external eye
  • Medical conditions that prohibit the use of systemic immunosuppression (in cases of allogenic transplantation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Antwerp

Antwerp, Edegem, 2650, Belgium

Location

Related Publications (1)

  • Zakaria N, Koppen C, Van Tendeloo V, Berneman Z, Hopkinson A, Tassignon MJ. Standardized limbal epithelial stem cell graft generation and transplantation. Tissue Eng Part C Methods. 2010 Oct;16(5):921-7. doi: 10.1089/ten.TEC.2009.0634.

    PMID: 19916804BACKGROUND

MeSH Terms

Conditions

Limbal Stem Cell DeficiencyAniridiaStevens-Johnson SyndromePterygium

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesEye AbnormalitiesEye Diseases, HereditaryIris DiseasesUveal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornStomatitisMouth DiseasesStomatognathic DiseasesDrug EruptionsDermatitisSkin DiseasesSkin and Connective Tissue DiseasesErythema MultiformeErythemaSkin Diseases, VesiculobullousHypersensitivity, DelayedHypersensitivityImmune System DiseasesDrug HypersensitivityDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersConjunctival Diseases

Study Officials

  • Nadia Zakaria, MBBS, PhD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

  • Carina Koppen, MD, PhD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

  • Marie J Tassignon, MD, PhD

    University Hospital, Antwerp

    STUDY DIRECTOR

  • Zwi Berneman, MD,PhD

    University Hospital, Antwerp

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. Marie-Jose Tassignon

Study Record Dates

First Submitted

February 17, 2009

First Posted

February 18, 2009

Study Start

July 1, 2008

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 20, 2013

Record last verified: 2013-06

Locations

BE(1)