A Phase 1/2 interventional study of Cultured limbal stem cells Transplantation in Limbal Stem Cell Deficiency, sponsored by Royan Institute. Completed at 2 sites in Iran, Islamic Republic of. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-07-15.
Sponsored by Royan Institute · Phase 1/2, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy, safety, and long term outcomes of ex vivo cultured limbal stem cell on amniotic membrane transplantation for corneal surface reconstruction in cases of partial and sever limbal stem cell deficiency.
Ocular surface is composed of corneal and conjunctival epithelial cells. Normal cornea is essential for normal vision. Defects in renewal and repair of ocular surface as a result of limbal stem cell deficiency are now known to cause varying ocular surface morbidity including persistent photophobia, repeated and persistent surface breakdown and overt conjunctivalisation of the cornea. Restoring ocular health in these eyes has traditionally been frustrating. Ex vivo cultured limbal epithelial stem cells have been used successfully to treat limbal stem cell deficiency. Ex-vivo limbal stem cell allograft transplantation is achieved by harvesting limbal corneal tissue from donor eyes (either matched living relatives or cadaveric donors). The donor stem cells are obtained by excising a small area of the conjunctiva at the limbus and are a minor procedure. The tissue so obtained is then grown in tissue culture and once the cells have multiplied sufficiently, small sheets are transplanted on to the affected eye(s), backed with an amniotic membrane. The surgery is undertaken under either local or general anesthesia.
40 studies on the registry are indexed under Limbal Stem Cell Deficiency; 15 are open to participants now.
This study's enrollment of 10 is below the median of 20 across 25 interventional studies indexed under Limbal Stem Cell Deficiency.
Browse Limbal Stem Cell Deficiency studies →Royan Institute is the lead sponsor of 92 studies on the registry; 3 are open to participants now.
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Cultured limbal stem cells Transplantation
Procedure: Cultured limbal stem cells Transplantation
Transplantation of cultivated limbal epithelium on amniotic membrane
Also known as: Transplantation
Snellen visual acuity
Time frame: 6 months
corneal epithelial integrity and stability
Time frame: 6 months
Impression cytology
Time frame: 12 months
Extent of retarding recurrent neovascularisation
Time frame: 12 months
This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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Royan Institute