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| Name | Class |
|---|---|
| Small Business Developing Center | UNKNOWN |
| Labafi Nejad Eye Research Center | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Cultured limbal stem cells Transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cultured limbal stem cells Transplantation | Procedure | Transplantation of cultivated limbal epithelium on amniotic membrane |
|
| Measure | Description | Time Frame |
|---|---|---|
| Snellen visual acuity | 6 months | |
| corneal epithelial integrity and stability | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Impression cytology | 12 months | |
| Extent of retarding recurrent neovascularisation | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hamid Gorabi, PhD | Royan institute, Tehran, Iran | Study Chair |
| Mohammadali Javadi, MD | Labbafinejad Ophthalmic Research Center, Tehran, Iran | Study Chair |
| Hossein Baharvand, PhD | Royan institute, Tehran, Iran | Principal Investigator |
| Alireza Baradaran, MD | Labbafinejad, Ophthalmic Research Center, Tehran, Iran | Principal Investigator |
| Marzieh Ebrahimi, PhD | Royan Institute, Tehran, Iran | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royan Institute | Tehran | Tehran Province | 1665659911 | Iran | ||
| Labbafinejad Ophthalmic Research Center |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D000092423 | Limbal Stem Cell Deficiency |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014180 | Transplantation |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Tehran |
| Tehran Province |
| 16666 |
| Iran |