hPSCreg®
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First-in-human clinical research of iPS derived corneal epithelial cell sheet transplantation for patients with limbal stem-cell deficiency

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
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.

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
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
Japan
Study sites
Public contact
Email ips_cornea@ophthal.med.osaka-u.ac.jp
Public email ips_cornea@ophthal.med.osaka-u.ac.jp
First name Takeshi
Last name Soma
Phone +81 (0)6-6879-3456
City Osaka
Country
Japan
Sponsors Department of Ophthalmology, Osaka University Graduate School of Medicine

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.

Recruitment
Recruitment Status Recruiting
Estimated number of participants 4
Contact institutions/departments