The clinical trial of human embryonic stem cell derived epithelial cells transplantation in the treatment of severe ocular surface diseases

General Information

Clinical trials phase Alternative regulatory mechanism
Start date (estimated) 2015-10-01
End date (estimated) 2018-12-28
Clinical feature
Label Limbal stem cell deficiency
Link http://www.orpha.net/ORDO/Orphanet_171673
Description A rare corneal disorder characterized by dysfunction and/or insufficient quantity of corneal limbal stem cells, leading to impaired self-renewal of the corneal epithelium and resulting in epithelial breakdown, corneal conjunctivalization and neovascularization, chronic inflammation, persistent epithelial defects, and scarring. Patients usually present with ocular redness, decreased vision, photophobia, foreign body sensation, tearing, and pain. The condition may be genetic, idiopathic, or acquired (in the context of inflammation, infection, trauma, or ocular surface tumors).

Administrative Information

ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR-OCB-15005968
Other study identifiers
Name ChiCTR-OCB-15005968
Description Chinese Clinical Trial Registry (ChiCTR)
Source weblink http://www.chictr.org.cn/showproj.aspx?proj=9595
Regulatory body approval
Name Ethic committee of Xiamen University affiliated Xiamen Eye Center 
Approval number 2014-ME-007
Sponsors Eye Institute of Xiamen University

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.)

Recruitment

Recruitment Status Recruiting
Estimated number of participants 20