- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02318485
Limbal Epithelial Stem Cell Transplantation: a Phase II Multicenter Trial (MLEC)
Translational Stem Cell Research in Ophthalmology - Regenerating the Anterior Cornea Through Standardized Transplantation of Limbal Epithelial Stem Cells: a Phase II Multicenter Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This project aims to conduct a multicenter, single-arm phase II study, in which we will assess the safety and efficacy of transplanting standardized, non-xenogenic limbal stem cell grafts for patients with LSCD. The Good Manufacturing Practice (GMP) clean room facilities at the Centre for Cell Therapy and Regenerative Medicine (CCRG, UZA) will conduct tissue engineering, while the Departments of Ophthalmology at the University Hospitals in Antwerp (UZA), Brussels (UZB) and Gent (UZG) will enrol patients, perform pre-operative tests, harvest the limbal biopsies, perform the auto- or allogenic graft transplantation and follow-up. Based on the past experience from our phase I/II mono-centre human clinical trial, we have been able to document the safety and feasibility of the transplantation. 12/18 patients (2/3 allogenic and 10/15 autologous) have shown decrease in corneal vascularization, complete epithelialization and incorporation of the graft into the anterior cornea post limbal stem cell transplantation. However our current results are limited with respect to the sample size, feasibility of allogenic transplantation (only 3 cases), long term follow-up (mean of 22 months, range 4-43 months) and disease monitoring strategies. Longer patient follow-up to determine long term success (especially following subsequent corneal transplants) and inclusion of a larger allogenic patient population need to be addressed before this treatment can be translated to the clinics and recognized by the RIZIV as a reimbursable cell therapy.
It is pertinent to say that this cell based therapy has the potential to provide this orphan pathology with an effective treatment option. The Flemish society will benefit from this project by improved rehabilitation of patients suffering from corneal blindness due to LSCD. By providing this treatment option we can offer a ray of hope to patients that would formerly have to learn to live with their disability. By restoring vision for these patients it is possible to reintegrate them into society as socially accepted individuals. Even a small degree of visual rehabilitation can make all the difference. For example, a slight increase in visual acuity can restore a person's ability to drive rather than having them rely exclusively on public transportation. More independence and a better quality of life are the main objectives that we are striving to achieve as the major outcome of this project.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Brussels, Belgium, 1090
- Recruiting
- University Hospital Brussels
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Contact:
- Josephine Behaegel, MD
- Phone Number: +32/2/477
- Email: Josephine.Behaegel@uzbrussel.be
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Principal Investigator:
- Marcel Ten Tuscher, MD
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Gent, Belgium, 9000
- Recruiting
- University Hospital, Ghent
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Contact:
- Josephine Behaegel, MD
- Email: Josephine.Behaegel@uza.be
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Principal Investigator:
- Bart P Leroy, MD
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Antwerp
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Edegem, Antwerp, Belgium, 2650
- Recruiting
- Antwerp University Hospital
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Contact:
- Josephine Behaegel, MD
- Phone Number: +3238214524
- Email: Josephine.Behaegel@uza.be
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Contact:
- Eline Melsbah
- Email: Eline.Melsbach@uza.be
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Sub-Investigator:
- Sorcha Ni Dhubhghaill, MD/PhD
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Sub-Investigator:
- Carina Koppen, MD/PhD
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Sub-Investigator:
- Josephine Behaegel, MD
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Sub-Investigator:
- Michel Haagdorens, MD
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Principal Investigator:
- Marie-Jose Tassignon, MD/PhD
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Principal Investigator:
- Nadia Zakaria, MD/PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults ≥ 18 years
- Voluntary written informed consent
- 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. Negative serum or urine β-HCG pregnancy test at screening.
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
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Transplant
A limbal epithelial stem cell graft will be transplanted onto the limbal stem cell deficient eye after it has been debrided of fibrovascular pannus
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual acuity
Time Frame: one year
|
using Log MAR scale
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one year
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presence of persistent epithelial defects
Time Frame: 3 months post surgery
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using Fluorescein drops and cobalt blue filter photography at the slit lamp
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3 months post surgery
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presence of corneal conjunctivalization
Time Frame: one year
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slit lamp photography and in vivo confocal microscopy
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one year
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change in corneal vascularization
Time Frame: one year
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slit lamp photography
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one year
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pain
Time Frame: one year
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using visual pain scale
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one year
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photophobia
Time Frame: one year
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using a 4 point scale
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one year
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Rejection
Time Frame: one year
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Increased neovascularization, epithelial defects and a drop in visual acuity Redness Pain Irritation slit lamp examination
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one year
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CCRG13-003
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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The S.N. Fyodorov Eye Microsurgery State InstitutionRecruitingLimbal Stem-cell DeficiencyRussian Federation
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University of California, Los AngelesNational Eye Institute (NEI); California Institute for Regenerative Medicine...Recruiting
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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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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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Royan InstituteCompletedLimbal Stem Cell Deficiency (LSCD)
Clinical Trials on Limbal epithelial stem cell graft
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Massachusetts Eye and Ear InfirmaryDana-Farber Cancer InstituteCompletedLimbal Stem Cell DeficiencyUnited States
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Ethisch Comité UZ AntwerpenAgentschap voor Innovatie door Wetenschap en Technologie; Fund for Scientific... and other collaboratorsUnknownLimbal Stem Cell DeficiencyBelgium
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CliPS Co., LtdCompletedLimbus Corneae Insufficiency Syndrome | Limbus CorneaeKorea, Republic of
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University College, LondonMedical Research CouncilWithdrawnTracheal Stenosis | Laryngostenosis | Disorder of Upper Respiratory SystemUnited Kingdom
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Shanghai iCELL Biotechnology Co., Ltd, Shanghai...Not yet recruiting
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L.V. Prasad Eye InstituteUnknownCorneal Injuries | Corneal Scars and Opacities | Corneal BurnsIndia
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Chunxiao WangCompleted
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Astellas Institute for Regenerative MedicineEnrolling by invitationMacular Degenerative DiseaseUnited Kingdom, United States