To evaluate the safety and effectiveness of human ex vivo expanded autologous limbal stem cells for the treatment of unilateral total limbal stem cell deficiency - Treatment of LSCD using cultured limbal epithelium expanded ALSC. V3.0

The Newcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 24 人开始时间: 2011年3月30日最近更新: 2018年5月28日

试验速览

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•Patient has provided written informed consent for participation in the study prior to any study specific procedures; • Patients must be 18 years of age or older and consent to have their data included in the database for research purposes; • Patients must be prepared and able to complete questionnaires; • Diagnosis of unilateral total LSCD (confirmed by impression cytology), with normal B scan ultrasound & electrophysiology; • No other ocular abnormality in recipient eye(s); • Women of child bearing potential must be using adequate contraception for duration of study and have a negative baseline pregnancy test as part of screening (post-consent).
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•Significant co-morbidity in which compliance with the study procedures would not be expected e.g. suspected insufficient cognitive ability to perform the tests (assessed using the 11-item Telephone Interview for Cognitive Status instrument); • Dry eye and eyelid abnormality in the affected eye; • Previous surgery to ocular surface of healthy contralateral donor eye; • Abnormal corneal impression cytology in healthy contralateral donor eye. • Pregnancy, or women planning to become pregnant within next 12 months, or women who are breast feeding; • Participating in other investigational study within 30 days prior to study entry (defined as date of enrolment/baseline visit into study); • Previous participation in this study.

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