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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00736307
First Posted: August 15, 2008
Last Update Posted: July 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Small Business Developing Center
Labafi Nejad Eye Research Center
Information provided by:
Royan Institute
  Purpose
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 Intervention Phase
Limbal Stem Cell Deficiency Procedure: Cultured limbal stem cells Transplantation Phase 1 Phase 2

Study Type: Interventional
Study Design: 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)

Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • Snellen visual acuity [ Time Frame: 6 months ]
  • corneal epithelial integrity and stability [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Impression cytology [ Time Frame: 12 months ]
  • Extent of retarding recurrent neovascularisation [ Time Frame: 12 months ]

Enrollment: 10
Study Start Date: October 2007
Study Completion Date: October 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cultured limbal stem cells Transplantation
Procedure: Cultured limbal stem cells Transplantation
Transplantation of cultivated limbal epithelium on amniotic membrane
Other Name: Transplantation

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736307


Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of, 1665659911
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
  More Information

Responsible Party: Hamid Gourabi/ Chief, Royan Institute
ClinicalTrials.gov Identifier: NCT00736307     History of Changes
Other Study ID Numbers: ROYAN-EYE-001
First Submitted: August 14, 2008
First Posted: August 15, 2008
Last Update Posted: July 15, 2011
Last Verified: April 2010

Keywords provided by Royan Institute:
limbal stem cell deficiency