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Study 2 of 155 for search of: | Iran, Islamic Republic of |
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Sponsors and Collaborators: |
Royan Institute Small Business Developing Center Labafi Nejad Eye Research Center |
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Information provided by: | Royan Institute |
ClinicalTrials.gov Identifier: | NCT00736307 |
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 |
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Limbal Stem Cell Deficiency |
Procedure: Cultured limbal stem cells Transplantation |
Phase I Phase II |
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) |
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 |
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1: Experimental
Cultured limbal stem cells Transplantation
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Procedure: Cultured limbal stem cells Transplantation
Transplantation of cultivated limbal epithelium on amniotic membrane
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nasser Aghdami, MD., PhD | (98)2126300017 | nasser.aghdami@royaninstitute.org |
Contact: Marzieh Ebrahimi, PhD | (98)2122518282 | marzieh_99@yahoo.com |
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 |
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 |
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 |
limbal stem cell deficiency |