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

Phase 2

Completed

• Conditions: Topic: Eye; Subtopic: Eye (all Subtopics); Disease: Ophthalmology; Eye Diseases

• Registration Number: ISRCTN51772481
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36708444/ (added 30/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-27
• Study Completion: 2018-01-31
• Last Update Posted: 13 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Patient has provided written informed consent for participation in the study prior to any study-specific procedures
2. Patients must be 18 years of age or older and consent to have their data included in the database for research purposes
3. Patients must be prepared and able to complete questionnaires
4. Diagnosis of unilateral total LSCD (confirmed by impression cytology), with normal B scan ultrasound and electrophysiology
5. No other ocular abnormality in recipient eye(s)
6. Women of childbearing potential must be using adequate contraception for duration of study and have a negative baseline pregnancy test as part of screening (postconsent)

Exclusion Criteria

1. Significant comorbidity 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)
2. Dry eye and eyelid abnormality in the affected eye
3. Previous surgery to the ocular surface of the healthy contralateral donor eye
4. Abnormal corneal impression cytology in the healthy contralateral donor eye
5. Pregnancy, or women planning to become pregnant within next 36 months, or women who are breastfeeding
6. Participating in other investigational study within 30 days prior to study entry (defined as date of enrolment/baseline visit into study)
7. Previous participation in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified