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

July 14, 2011 updated by: Royan Institute

Transplantation of Ex-Vivo Expanded Human Limbal Epithelial Stem Cells (LSC) on Amniotic Membrane (AM) for Limbal Stem Cell Deficiency (LSCD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 1665659911
        • Royan Institute
      • Tehran, Iran, Islamic Republic of, 16666
        • Labbafinejad Ophthalmic Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Cultured limbal stem cells Transplantation
Procedure: Cultured limbal stem cells Transplantation
Transplantation of cultivated limbal epithelium on amniotic membrane
Other Names:
  • Transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Snellen visual acuity
Time Frame: 6 months
6 months
corneal epithelial integrity and stability
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Impression cytology
Time Frame: 12 months
12 months
Extent of retarding recurrent neovascularisation
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royan Institute

Collaborators

Small Business Developing Center
Labafi Nejad Eye Research Center

Investigators

  • Study Chair: Hamid Gorabi, PhD, Royan Institute, Tehran, Iran
  • Principal Investigator: Hossein Baharvand, PhD, Royan Institute, Tehran, Iran
  • Study Chair: Mohammadali Javadi, MD, Labbafinejad Ophthalmic Research Center, Tehran, Iran
  • Principal Investigator: Alireza Baradaran, MD, Labbafinejad, Ophthalmic Research Center, Tehran, Iran
  • Study Director: Marzieh Ebrahimi, PhD, Royan Institute, Tehran, Iran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

August 14, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (Estimate)

August 15, 2008

Study Record Updates

Last Update Posted (Estimate)

July 15, 2011

Last Update Submitted That Met QC Criteria

July 14, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ROYAN-EYE-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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