Limbal Stem Cell DeficiencyLECTNCT00845117
Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency
A study testing Cultivated limbal stem cell graft transplantation in people with Limbal Stem Cell Deficiency, run by Veerle Van Gerwen at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Limbal Stem Cell Deficiency
- What is being tested?
- Cultivated limbal stem cell graft transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2008to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Cultivated limbal stem cell graft transplantation
- Keywords
- Aniridia,, Steven Johnsons Syndrome,, Ocular burns,, Pterygium
- Medical subject headings
- Limbal Stem Cell Deficiency, Aniridia, Stevens-Johnson Syndrome, Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultivated limbal stem cell graft transplantationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Cultivated limbal stem cell graft transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Measured: Just before surgery and upto 1 years after surgery
Conjunctivalization
Measured: Just before surgery and upto 1 years after surgery
Vascularization
Measured: Just before surgery and upto 1 years after surgery
Epithelialization
Measured: Just before surgery and upto 1 years after surgery
Secondary outcomes (1)
Prolonged subsequent corneal graft survival time
Measured: 1 year post corneal transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startJul 2008
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Limbal Stem Cell DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veerle Van Gerwen
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, European Society of Cataract and Refractive Surgeons, Agentschap voor Innovatie door Wetenschap en Technologie
- Responsible party
- Sponsor-investigator, Veerle Van Gerwen, University Hospital, Antwerp
- Investigators
- Nadia Zakaria, MBBS, PhD, Principal investigator, University Hospital, AntwerpCarina Koppen, MD, PhD, Principal investigator, University Hospital, AntwerpMarie J Tassignon, MD, PhD, Study director, University Hospital, AntwerpZwi Berneman, MD,PhD, Study chair, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845117
- Sponsor's protocol ID
- EC 7/28/153
- Acronym
- LECT
- Status last verified
- Jun 2013
- First submitted
- 17 Feb 2009
- Last updated
- 18 Jun 2026
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency
- ClinicalTrials.gov ID
- NCT00845117
- Acronym / sponsor ID
- LECT / EC 7/28/153
- Conditions
- Limbal Stem Cell Deficiency
- Keywords
- Aniridia,, Steven Johnsons Syndrome,, Ocular burns,, Pterygium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Veerle Van GerwenUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, European Society of Cataract and Refractive Surgeons, Agentschap voor Innovatie door Wetenschap en Technologie
- Study start
- Jul 2008
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Limbal Stem Cell Transplant | Experimental | Procedure: Cultivated limbal stem cell graft transplantationThe cornea is debrided of all superficial fibrovascular tissue and the cultivated stem cell graft is glued onto the cornea. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cultivated limbal stem cell graft transplantationA 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. | Procedure or surgery | Limbal Stem Cell Transplant |
Primary outcome
Visual Acuity
Time frame: Just before surgery and upto 1 years after surgery
Conjunctivalization
Time frame: Just before surgery and upto 1 years after surgery
Vascularization
Time frame: Just before surgery and upto 1 years after surgery
Epithelialization
Time frame: Just before surgery and upto 1 years after surgery
1 secondary outcome
Prolonged subsequent corneal graft survival time
Time frame: 1 year post corneal transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Background: PubMed 19916804Zakaria 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cultivated limbal stem cell graft transplantation in people with Limbal Stem Cell Deficiency, run by Veerle Van Gerwen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: Just before surgery and upto 1 years after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00845117, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.