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Autologous Transplantation of Cultivated Limbal Stem Cells on Amniotic Membrane in Limbal Stem Cell Deficiency (LSD) Patients
This study is currently recruiting participants.
Verified by Royan Institute, August 2008
Sponsors and Collaborators: Royan Institute
Small Business Developing Center
Labafi Nejad Eye Research Center
Information provided by: Royan Institute
ClinicalTrials.gov Identifier: NCT00736307
  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 I
Phase II

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
  • corneal epithelial integrity and stability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Impression cytology [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Extent of retarding recurrent neovascularisation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: October 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Cultured limbal stem cells Transplantation
Procedure: Cultured limbal stem cells Transplantation
Transplantation of cultivated limbal epithelium on amniotic membrane

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736307

Contacts
Contact: Nasser Aghdami, MD., PhD (98)2126300017 nasser.aghdami@royaninstitute.org
Contact: Marzieh Ebrahimi, PhD (98)2122518282 marzieh_99@yahoo.com

Locations
Iran, Islamic Republic of
Royan Institute Recruiting
Tehran, Iran, Islamic Republic of, 1665659911
Contact: Marzieh Ebrahimi, PhD     (98)2122518282     marzieh_99@yahoo.com    
Sub-Investigator: Ehsan Taghiabadi, Msc            
Labbafinejad Ophthalmic Research Center Recruiting
Tehran, Iran, Islamic Republic of, 16666
Contact: Alireza Baradaran, MD     (98)2122587317     labbafi@hotmail.com    
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

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Royan Institute ( Hamid Gourabi/ Chief )
Study ID Numbers: ROYAN-EYE-001
Study First Received: August 14, 2008
Last Updated: August 14, 2008
ClinicalTrials.gov Identifier: NCT00736307  
Health Authority: Iran: Ministry of Health

Keywords provided by Royan Institute:
limbal stem cell deficiency

ClinicalTrials.gov processed this record on January 16, 2009