General Information |
| Description |
The objectives of this clinical research are to evaluate the safety as well as the feasibility and efficacy of transplantation of iPS derived corneal epithelial cell sheet (iCEPS) for LSCD patients. |
| Clinical trials phase |
Phase 1 |
| Start date (estimated) |
2019-05-23 |
| End date (estimated) |
2021-12-13 |
| Clinical feature |
| Label |
Limbal stem cell deficiency |
| Link |
http://purl.obolibrary.org/obo/HP_0032107 |
| Description |
A condition characterized by a loss or deficiency of the stem cells in the limbus that are vital for re-population of the corneal epithelium and to the barrier function of the limbus.; The corneal epithelium covers the corneal surface and plays a major role in protection and transparency. Epithelial cells are shed regularly and replaced by stem cell sources located at the limbus, a rim of tissue located at the junction of the cornea and sclera. The limbal epithelial stem cells reside in specific regions at the limbus known as the limbal stem cell niches. Damage to the stem cells or disruption of the niches may lead to Limbal Stem Cell Deficiency. In the absence of a healthy corneal epithelium, the conjunctiva proliferates over the cornea resulting in opacification and vascularization, which in turn may lead to reduced vision, pain, and photophobia. |
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| Publications |
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Administrative Information |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=JPRN-UMIN000036539 |
| Other study identifiers |
| Name |
UMIN000036539 |
| Description |
UMIN Clinical Trials Registry (UMIN-CTR |
| Name |
jRCTa050190084 |
| Description |
Japan Registry of Clinical Trials |
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| Source weblink |
https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041628 |
| Regulatory body approval |
| Name |
The First Certified Special Committee for Regenerative Medicine, Osaka University |
| Country |
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| Study sites |
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| Sponsors |
Department of Ophthalmology, Osaka University Graduate School of Medicine
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Cells |
| Which differentiated cell type is used |
| Label |
corneal epithelial cell |
| Link |
http://purl.obolibrary.org/obo/CL_0000575 |
| Description |
An epithelial cell of the cornea.; Corneal epithelial cells are a specialized cell type that form the outermost layer of the cornea, the transparent dome-shaped tissue that covers the front of the eye. The corneal epithelium is 5-7 cells thick and is comprised of inner basal cells, middle wing cells and superficial squamous cells.
The corneal epithelium plays a crucial role in the maintenance of corneal transparency, protection against external insults, and the refractive power of the cornea. This cell type is responsible for the formation of tight junctions, desmosomes, and hemidesmosomes, which provide structural support to the corneal epithelium and prevent the infiltration of foreign particles and microorganisms.
Corneal epithelial cells also have a unique and highly organized cytoskeleton that confers mechanical integrity and limits the penetration of foreign substances. Additionally, corneal epithelial cells secrete a variety of proteins and lipids that help to maintain the hydration and clarity of the cornea. These include mucins, which form a lubricating layer that facilitates blinking and limits dryness, and crystallins, which appear to protect against UV- and oxidative stress-induced apoptosis.
Dysfunction of corneal epithelial cells due to infections, inflammation, or injury can lead to corneal opacity, scarring, and impaired vision.
(This extended description was generated by ChatGPT and reviewed by the CellGuide team, who added references, and by the CL editors, who approved it for inclusion in CL. It may contain information that applies only to some subtypes and species, and so should not be considered definitional.) |
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Recruitment |
| Recruitment Status |
Completed |
| Comment recruitment status |
Complete: follow-up complete |
| Estimated number of participants |
4 |
| Contact institutions/departments |
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