Transplantation of Cultivated Corneal Epithelial Sheet in Patients With Ocular Surface Disease (NCT01123044) | Clinical Trial Compass
UnknownPhase 3
Transplantation of Cultivated Corneal Epithelial Sheet in Patients With Ocular Surface Disease
Malaysia42 participantsStarted 2011-08
Plain-language summary
The aim of the study is to assess if transplantation of cultivated corneal epithelial stem cells could restore vision in patients with severe ocular surface disorder with a favourable safety profile that warrants further comparative study.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or non-pregnant females between 18 and 75 years of age.
✓. Written informed consent obtained from patient or parents/guardian.
✓. Patients with unilateral limbal stem deficiency 2-12 months presenting with any of the following
✓. Patients who had 2-12 months of conservative treatment. \* Diagnostic criteria for limbal stem cell deficiency are as follows:
Exclusion criteria
✕. Pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test.
✕. Participation in any drug trial in which the patient received an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the screening phase of this study.
✕. Those persons directly involved in the conduct of the study.
✕. Any history of severe infection such as hepatitis, renal, gastrointestinal, endocrine or neurological disease.
✕. Evidence of corneal stromal scarring, cataract, macular oedema or scarring, retinal detachment and conjunctival keratinisation
✕. Positive for HIV, Hepatitis B, C and VDRL
✕. History of Pulmonary tuberculosis, hepatitis B,