Limbal Stem Cell Deficiency
Conditions
Keywords
Aniridia,, Steven Johnsons Syndrome,, Ocular burns,, Pterygium
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.
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.
Sponsors
Veerle Van Gerwen
Fund for Scientific Research, Flanders, Belgium
European Society of Cataract and Refractive Surgeons
Agentschap voor Innovatie door Wetenschap en Technologie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Prolonged subsequent corneal graft survival time | 1 year post corneal transplant |
Countries
Belgium
Contacts
PRINCIPAL_INVESTIGATORNadia Zakaria, MBBS, PhD
University Hospital, Antwerp
PRINCIPAL_INVESTIGATORCarina Koppen, MD, PhD
University Hospital, Antwerp
STUDY_DIRECTORMarie J Tassignon, MD, PhD
University Hospital, Antwerp
STUDY_CHAIRZwi Berneman, MD,PhD
University Hospital, Antwerp
Outcome results
None listed