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

NCT ID: NCT00736307

Last Updated: 2011-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-10-31

Brief Summary

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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

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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.

Conditions

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Limbal Stem Cell Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Cultured limbal stem cells Transplantation

Group Type EXPERIMENTAL

Cultured limbal stem cells Transplantation

Intervention Type PROCEDURE

Transplantation of cultivated limbal epithelium on amniotic membrane

Interventions

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Cultured limbal stem cells Transplantation

Transplantation of cultivated limbal epithelium on amniotic membrane

Intervention Type PROCEDURE

Other Intervention Names

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Transplantation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Small Business Developing Center

UNKNOWN

Sponsor Role collaborator

Labafi Nejad Eye Research Center

UNKNOWN

Sponsor Role collaborator

Royan Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Royan Institute

Principal Investigators

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Hamid Gorabi, PhD

Role: STUDY_CHAIR

Royan institute, Tehran, Iran

Mohammadali Javadi, MD

Role: STUDY_CHAIR

Labbafinejad Ophthalmic Research Center, Tehran, Iran

Hossein Baharvand, PhD

Role: PRINCIPAL_INVESTIGATOR

Royan institute, Tehran, Iran

Alireza Baradaran, MD

Role: PRINCIPAL_INVESTIGATOR

Labbafinejad, Ophthalmic Research Center, Tehran, Iran

Marzieh Ebrahimi, PhD

Role: STUDY_DIRECTOR

Royan Institute, Tehran, Iran

Locations

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Royan Institute

Tehran, Tehran Province, Iran

Site Status

Labbafinejad Ophthalmic Research Center

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Related Links

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Other Identifiers

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ROYAN-EYE-001

Identifier Type: -

Identifier Source: org_study_id

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