Autologous Transplantation of Cultivated Limbal Stem Cells on Amniotic Membrane in Limbal Stem Cell Deficiency (LSD) Patients

Phase 1

Completed

• Conditions: Limbal Stem Cell Deficiency
• Interventions: Procedure: Cultured limbal stem cells Transplantation

• Registration Number: NCT00736307
• Lead Sponsor: Royan Institute

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.

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 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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-08-14
• Study First Submitted QC: 2008-08-14
• Study First Posted: 2008-08-15
• Primary Completion: 2009-07
• Study Completion: 2009-10
• Status Verified: 2010-04
• Last Update Submitted: 2011-07-14
• Last Update Posted: 2011-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Cultured limbal stem cells Transplantation	Cultured limbal stem cells Transplantation

Primary Outcome Measures

Name	Time	Method
Snellen visual acuity	6 months
corneal epithelial integrity and stability	6 months

Secondary Outcome Measures

Name	Time	Method
Impression cytology	12 months
Extent of retarding recurrent neovascularisation	12 months

Trial Locations

Locations (2)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of

Labbafinejad Ophthalmic Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of