- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00845117
Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency (LECT)
June 19, 2013 updated by: Ethisch Comité UZ Antwerpen
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Edegem
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Antwerp, Edegem, Belgium, 2650
- University Hospital Antwerp
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation
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 immunosuppression (in cases of allogenic transplantation)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual Acuity
Time Frame: Just before surgery and upto 1 years after surgery
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Just before surgery and upto 1 years after surgery
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Conjunctivalization
Time Frame: Just before surgery and upto 1 years after surgery
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Just before surgery and upto 1 years after surgery
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Vascularization
Time Frame: Just before surgery and upto 1 years after surgery
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Just before surgery and upto 1 years after surgery
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Epithelialization
Time Frame: Just before surgery and upto 1 years after surgery
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Just before surgery and upto 1 years after surgery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prolonged subsequent corneal graft survival time
Time Frame: 1 year post corneal transplant
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1 year post corneal transplant
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nadia Zakaria, MBBS, PhD, University Hospital, Antwerp
- Principal Investigator: Carina Koppen, MD, PhD, University Hospital, Antwerp
- Study Director: Marie J Tassignon, MD, PhD, University Hospital, Antwerp
- Study Chair: Zwi Berneman, MD,PhD, University Hospital, Antwerp
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Anticipated)
June 1, 2014
Study Completion (Anticipated)
June 1, 2014
Study Registration Dates
First Submitted
February 17, 2009
First Submitted That Met QC Criteria
February 17, 2009
First Posted (Estimate)
February 18, 2009
Study Record Updates
Last Update Posted (Estimate)
June 20, 2013
Last Update Submitted That Met QC Criteria
June 19, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- EC 7/28/153
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Limbal Stem Cell Deficiency
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University of California, Los AngelesNational Eye Institute (NEI); California Institute for Regenerative Medicine...Recruiting
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The S.N. Fyodorov Eye Microsurgery State InstitutionRecruitingLimbal Stem-cell DeficiencyRussian Federation
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National Taiwan University HospitalRecruiting
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Klinikum Chemnitz gGmbHInstitute of Anatomy TU DresdenCompletedLimbal Stem-cell Deficiency
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Royan InstituteSmall Business Developing Center; Labafi Nejad Eye Research CenterCompletedLimbal Stem Cell DeficiencyIran, Islamic Republic of
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National Taiwan University HospitalRecruiting
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CHU de Quebec-Universite LavalRecruitingLimbal Stem Cell DeficiencyCanada
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Siriraj HospitalOsaka UniversityCompletedLimbal Stem-cell DeficiencyThailand
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CellSeed France S.A.R.L.FGK Clinical Research GmbHWithdrawnLimbal Stem Cell DeficiencyGermany
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RHEACELL GmbH & Co. KGFGK Clinical Research GmbH; Ticeba GmbH; Granzer Regulatory Consulting & ServicesActive, not recruitingLimbal Stem Cell DeficiencyUnited States, Germany
Clinical Trials on Cultivated limbal stem cell graft transplantation
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Massachusetts Eye and Ear InfirmaryDana-Farber Cancer InstituteCompletedLimbal Stem Cell DeficiencyUnited States
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Ethisch Comité UZAUniversity Hospital, Ghent; Universitair Ziekenhuis BrusselUnknownLimbal Stem Cell DeficiencyBelgium
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Instituto de Oftalmología Fundación Conde de ValencianaNational Council of Science and Technology, MexicoTerminatedLimbal Stem Cell DeficiencyMexico
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Mahidol UniversityCompletedLimbal Deficiency | Severe Ocular Surface DamageThailand
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L.V. Prasad Eye InstituteUnknownCorneal Injuries | Corneal Scars and Opacities | Corneal BurnsIndia
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Singapore National Eye CentreSingapore Eye Research InstituteSuspended
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Royan InstituteSmall Business Developing Center; Labafi Nejad Eye Research CenterCompletedLimbal Stem Cell DeficiencyIran, Islamic Republic of
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Chang Gung Memorial HospitalRecruiting
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CliPS Co., LtdCompletedLimbus Corneae Insufficiency Syndrome | Limbus CorneaeKorea, Republic of
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L.V. Prasad Eye InstituteNot yet recruiting