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

Sponsor
Royan Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00736307
Collaborator
Small Business Developing Center (Other), Labafi Nejad Eye Research Center (Other)
10
Enrollment
2
Locations
1
Arm
24
Duration (Months)
5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cultured limbal stem cells Transplantation
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Transplantation of Ex-Vivo Expanded Human Limbal Epithelial Stem Cells (LSC) on Amniotic Membrane (AM) for Limbal Stem Cell Deficiency (LSCD)
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Jul 1, 2009
Actual Study Completion Date :
Oct 1, 2009

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Snellen visual acuity [6 months]

    2. corneal epithelial integrity and stability [6 months]

    Secondary Outcome Measures

    1. Impression cytology [12 months]

    2. Extent of retarding recurrent neovascularisation [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royan Institute Tehran Iran, Islamic Republic of 1665659911
    2 Labbafinejad Ophthalmic Research Center Tehran Iran, Islamic Republic of 16666

    Sponsors and Collaborators

    • Royan Institute
    • Small Business Developing Center
    • Labafi Nejad Eye Research Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00736307
    Other Study ID Numbers:
    • ROYAN-EYE-001
    First Posted:
    Aug 15, 2008
    Last Update Posted:
    Jul 15, 2011
    Last Verified:
    Apr 1, 2010
    Keywords provided by , ,
    limbal stem cell deficiency

    Study Results

    No Results Posted as of Jul 15, 2011