Translational stem cell research in ophthalmology - regenerating the anterior cornea through standardized transplantation of limbal epithelial stem cells: a phase II multicenter trial

Antwerp University Hospital (UZA)0 sites60 target enrollmentStarted: December 4, 2013Last updated: February 2, 2015

Overview

No summary available.

•1\. Voluntary written informed consent
•2\. 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.
•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. Negative serum or urine ß\-HCG pregnancy test at screening.
•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 30
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 30

•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)

Sponsor

Antwerp University Hospital (UZA)