Autologous Transplantation of Cultivated Limbal Stem Cells on Amniotic Membrane in Limbal Stem Cell Deficiency (LSD) Patients
Brief Summary
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.
Intervention / Treatment
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Cultured limbal stem cells Transplantation (PROCEDURE)Transplantation of cultivated limbal epithelium on amniotic membrane
Condition or Disease
- Limbal Stem Cell Deficiency
Phase
Study Design
Study type: | INTERVENTIONAL |
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Status: | Completed |
Study results: | No Results Available |
Age: | 18 Years to 75 Years |
Enrollment: | 10 (ACTUAL) |
Allocation: | N/A |
Primary Purpose: | Treatment |
Masking |
Clinical Trial Dates
Start date: | Oct 01, 2007 | |
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Primary Completion: | Jul 01, 2009 | ACTUAL |
Completion Date: | Oct 01, 2009 | ACTUAL |
Study First Posted: | Aug 15, 2008 | ESTIMATED |
Last Updated: | Jul 14, 2011 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
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.
Eligibility Criteria
Sex: | All |
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Minimum Age: | 18 |
Maximum Age: | 75 |
Healthy Volunteers: | Yes |
Inclusion Criteria:
* Patient with unilateral limbal stem cell insufficiency and totally corneal vascularization
* Presence of Goblet cells on the cornea
* Minimum tear was about 5 mm
* Minimum duration of deficiency was 3 years
* Vision was Light Perception
Exclusion Criteria:
* Systemic disease affecting both eyes such as Stevens-Johnson syndrome
* Patient with unilateral limbal stem cell insufficiency and totally corneal vascularization
* Presence of Goblet cells on the cornea
* Minimum tear was about 5 mm
* Minimum duration of deficiency was 3 years
* Vision was Light Perception
Exclusion Criteria:
* Systemic disease affecting both eyes such as Stevens-Johnson syndrome
Primary Outcomes
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Snellen visual acuity 6 months
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corneal epithelial integrity and stability 6 months
Secondary Outcomes
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Impression cytology 12 months
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Extent of retarding recurrent neovascularisation 12 months
More Details
NCT Number: | NCT00736307 |
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Other IDs: | ROYAN-EYE-001 |
Study URL: | https://clinicaltrials.gov/study/NCT00736307 |
Last updated: Sep 29, 2023