To evaluate how safe and efficient the treatment of blind patients with total corneal scar caused by stem cell failure is, when using cells from the patient's healthy other eye grown in the laboratory.

Phase 1

Conditions: Therapeutic area: Diseases [C] - Eye Diseases [C11]
unilateral total limbal stem cell deficiency

Registration Number: EUCTR2011-000608-16-GB

Lead Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

• 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

Exclusion Criteria

• 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.