Patients suffering from Limbal Stem Cell Deficiency will be investigated during the course of this clinical trial.
Conditions
Interventions
Pharmaceutical Form:
Sponsors
Antwerp University Hospital (UZA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. Age: = 18 years 3. 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. 4. Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects who are pregnant or lactating 2. Subjects who have sensitivity to drugs that provide local anesthesia 3. Subjects suffering from active infection of the external eye 4. Medical conditions that prohibit the use of systemic immunosuppression (in cases of allogenic transplantation)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the success rate of transplanting bioengineered composite grafts of cultured limbal epithelial stem cells and the amniotic membrane – in patients with Limbal Stem cell Deficiency (LSCD). Based on the past experience from clinical centers performing Limbal stem cell transplantation, our primary hypothesis is that it will be well-tolerated, and not associated with serious adverse side effects.;Secondary Objective: The secondary objective of this study is to evaluate corneal re-epithelization resulting from transplanted limbal stem cells, in vivo: using slit lamp examination, and confocal scanning and ex vivo: using impression cytology and DNA analysis.;Primary end point(s): We will assess the success rate of transplanted limbal stem cells by a clinical observation of: Short term: 1.Increased visual acuity 2.Absence of conjunctivalization 3.Resolution of corneal vascularization 4.Absence of persistent epithelial defect 5.Decreased pain 6.Decreased photophobia Long term: 1.Prolonged subsequent corneal graft survival time | — |
Countries
Belgium
Outcome results
None listed