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 个研究点目标入组 60 人开始时间: 2013年12月4日最近更新: 2015年2月2日

适应症

试验速览

暂无简介。

•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)

发起方

Antwerp University Hospital (UZA)