Clinical trial NCT00736307: Autologous Transplantation of Cultivated Limbal Stem Cells on Amniotic Membrane in Limbal Stem Cell Deficiency (LSD) Patients
Official title: Transplantation of Ex-Vivo Expanded Human Limbal Epithelial Stem Cells (LSC) on Amniotic Membrane (AM) for Limbal Stem Cell Deficiency (LSCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Limbal Stem Cell Deficiency
Keywords: limbal stem cell deficiency
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
Collaborators: name: Small Business Developing Center
name: Labafi Nejad Eye Research Center
First posted: 2008-08-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Snellen visual acuity
timeFrame: 6 months
measure: corneal epithelial integrity and stability
timeFrame: 6 months
Secondary outcomes:
measure: Impression cytology
timeFrame: 12 months
measure: Extent of retarding recurrent neovascularisation
timeFrame: 12 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
city: Tehran
country: Iran, Islamic Republic of
facility: Labbafinejad Ophthalmic Research Center
Study officials:
affiliation: Royan institute, Tehran, Iran
name: Hamid Gorabi, PhD
role: STUDY_CHAIR
affiliation: Labbafinejad Ophthalmic Research Center, Tehran, Iran
name: Mohammadali Javadi, MD
role: STUDY_CHAIR
affiliation: Royan institute, Tehran, Iran
name: Hossein Baharvand, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Labbafinejad, Ophthalmic Research Center, Tehran, Iran
name: Alireza Baradaran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royan Institute, Tehran, Iran
name: Marzieh Ebrahimi, PhD
role: STUDY_DIRECTOR
References: