The Safety and Tolerability of Sub-retinal Transplantation of SCNT-hES-RPE Cells in Patients With Advanced Dry AMD

General Information

Summary To evaluate the safety and tolerability of human somatic cell nuclear transfer embryonic stem cell derived retinal pigmented epithelial(SCNT-hES-RPE) cellular therapy in patients with advanced dry AMD.
Description To evaluate the safety and tolerability of the SCNT-hES-RPEs, to assess the number of SCNT-hES-RPE cells to be transplanted in future studies and to evaluate on an exploratory basis potential efficacy endpoints to be used in future studies of SCNT-hES-RPE cellular therapy.
Clinical trials phase Phase 1
Start date (estimated) 2016-05-01
End date (estimated) 2019-04-30
Clinical feature
Label age related macular degeneration
Link http://purl.obolibrary.org/obo/DOID_10871
Description A degeneration of macula and posterior pole that is characterized by a loss of vision in the center of the visual field (the macula) resulting from damage to the retina and resulting in blurring of the sharp central vision.; OMIM mapping confirmed by DO. [SN].

Administrative Information

NCT number NCT03305029
ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03305029
Other study identifiers
Name CHA2015-08-141
Source weblink https://clinicaltrials.gov/ct2/show/NCT03305029
Public contact
Email songwkmd@daum.net
Sponsors CHA University

Cells

Which differentiated cell type is used
Label mesenchymal stem cell
Link http://purl.obolibrary.org/obo/CL_0000134
Description A connective tissue cell that normally gives rise to other cells that are organized as three-dimensional masses. In humans, this cell type is CD73-positive, CD90-positive, CD105-positive, CD45-negative, CD34-negative, and MHCII-negative. They may further differentiate into osteoblasts, adipocytes, myocytes, neurons, or chondroblasts in vitro. Originally described as residing in the bone marrow, this cell type is now known to reside in many, if not all, adult organs.; Many but not all mesenchymal cells derive from the mesoderm. MSCs are reportedly CD3-negative, CD4-negative, CD5-negative, CD8-negative, CD11a-negative, CD11b-negative, CD14-negative, CD19-negative, CD29-positive, CD31-negative, CD34-negative, CD38-negative, CD40-negative, CD44-positive, CD45-negative, CD49-positive, CD54-positive, CD66b-negative, CD79a-negative, CD80-negative, CD102-positive, CD106-positive, CD117-positive, CD121a-positive, CD121b-positive, CD123-positive, CD124-positive, CD133-negative, CD146-positive, CD166-positive, CD271-positive, B220-negative, Gr1-negative, MHCI-positive, MHCII-negative, SSEA4-negative, sca1-positive, Ter119-negative, and glycophorin A-negative. Cultured MSCs are capable of producing stem cell factor, IL7, IL8, IL11, TGF-beta, cofilin, galectin-1, laminin-receptor 1, cyclophilin A, and MMP-2.

Recruitment

Recruitment Status Unknown Status
Estimated number of participants 3
Contact institutions/departments