Status:
COMPLETED
Autologous Transplantation of Cultivated Limbal Stem Cells on Amniotic Membrane in Limbal Stem Cell Deficiency (LSD) Patients
Lead Sponsor:
Royan Institute
Collaborating Sponsors:
Small Business Developing Center
Labafi Nejad Eye Research Center
Conditions:
Limbal Stem Cell Deficiency
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 ca...
Detailed Description
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 d...
Eligibility Criteria
Inclusion
- 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
- Systemic disease affecting both eyes such as Stevens-Johnson syndrome
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00736307
Start Date
October 1 2007
End Date
October 1 2009
Last Update
July 15 2011
Active Locations (2)
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1
Royan Institute
Tehran, Tehran Province, Iran, 1665659911
2
Labbafinejad Ophthalmic Research Center
Tehran, Tehran Province, Iran, 16666