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 |
|
| 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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| 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 |
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| 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 |
Completed |
| Comment recruitment status |
Complete: follow-up complete |
| Estimated number of participants |
4 |
| Contact institutions/departments |
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