ClinicalTrials.gg
CompletedNCT00845117LECTUpdated Jun 18, 2026

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

An interventional study of Cultivated limbal stem cell graft transplantation in Limbal Stem Cell Deficiency, sponsored by Veerle Van Gerwen. Completed at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by Veerle Van Gerwen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Sex
All
01

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.

02

Conditions studied

  • Limbal Stem Cell Deficiency

Keywords

  • Aniridia,
  • Steven Johnsons Syndrome,
  • Ocular burns,
  • Pterygium
03

In context

Limbal Stem Cell Deficiency

38 studies on the registry are indexed under Limbal Stem Cell Deficiency; 15 are open to participants now.

This study's enrollment of 21 is close to the median of 20 across 23 interventional studies indexed under Limbal Stem Cell Deficiency.

Browse Limbal Stem Cell Deficiency studies →

Lead sponsor

This is the only study on the registry with Veerle Van Gerwen as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 should use adequate prior to study entry and for the duration of study participation

Exclusion criteria

Exclusion Criteria:

  • 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 (in cases of allogenic transplantation)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Limbal Stem Cell Transplant

    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

  • ProcedureCultivated 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.

06

What researchers measure

Primary outcomes

  1. Visual Acuity

    Time frame: Just before surgery and upto 1 years after surgery

  2. Conjunctivalization

    Time frame: Just before surgery and upto 1 years after surgery

  3. Vascularization

    Time frame: Just before surgery and upto 1 years after surgery

  4. Epithelialization

    Time frame: Just before surgery and upto 1 years after surgery

Secondary outcomes

  1. Prolonged subsequent corneal graft survival time

    Time frame: 1 year post corneal transplant

07

Study locations

1 site
  • University Hospital Antwerp
    Antwerp, Edegem 2650, Belgium
08

References and documents

Publications

  • 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. PubMed 19916804 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2008, a primary completion of Jun 2014 and a completion of Jun 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 17, 2009
First posted
Feb 18, 2009
Start
Jul 2008
Primary completionActual
Jun 2014
CompletionActual
Jun 2014
Last update
Jun 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00845117
Lead sponsor
Veerle Van Gerwen
Collaborators
Fund for Scientific Research, Flanders, Belgium, European Society of Cataract and Refractive Surgeons, Agentschap voor Innovatie door Wetenschap en Technologie
Responsible party
Veerle Van Gerwen (Prof. Dr. Marie-Jose Tassignon, University Hospital, Antwerp) — Sponsor-investigator
First posted
Feb 18, 2009
Start date
Jul 2008
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Jun 18, 2026

Study contacts

Nadia Zakaria, MBBS, PhD
principal investigator · University Hospital, Antwerp
Carina Koppen, MD, PhD
principal investigator · University Hospital, Antwerp
Marie J Tassignon, MD, PhD
study director · University Hospital, Antwerp
Zwi Berneman, MD,PhD
study chair · University Hospital, Antwerp
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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