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Stem Cell Therapy for Outer Retinal Degenerations

General Information

Summary This study is a Phase I/II , open label,non randomized, prospective study to determine the safety of human embryonic stem cell derived Retinal pigmented epithelium (hESC RPE) sub retinal injections versus hESC RPE seeded on a polymeric substrate implanted in the sub retinal space.
Description To determine whether the surgical implantation of a human embryonic stem cell-derived retinal pigmented epithelium (hESC-RPE) monolayer seeded onto a polymeric versus hESC-RPE injections into the sub retinal space is a safe procedure. 6 Patients will receive hESC-RPE cell injections (100000 cells) in the sub retinal space (2 Dry Age-related macular degeneration (AMD), 2 Wet AMD with disciform scar and 2 with Stargardt's disease). Also 5 patients Dry AMD, 5 patients with Wet AMD with disciform scar and 5 patients with Stargardt's disease with receive a subretinal implantation of the hESC-RPE seeded in a monolayer in a polymeric substrate. Patients will be enrolled sequentially, and after the procedure the patients will be followed for 1 year.
Clinical trials phase Phases 1/2
Start date (estimated) 2015-08-01
End date (estimated) 2019-06-30
Clinical feature
Label macular degeneration
Description A retinal degeneration characterized by gradual deterioration of light-sensing cells in the tissues at the back of the eye and has_symptom vision loss.; Xref MGI.

Administrative Information

NCT number NCT02903576
ICTRP weblink
Other study identifiers
Name 12018712.5.0000.5505
Source weblink
Regulatory body approval
Name National Committee of Ethics in Research
Public contact
Public email
First name Rodrigo AB
Last name Fernandes
Phone +5511972456473
Sponsors Federal University of São Paulo


Source pluripotent stem cell lines
Which differentiated cell type is used
Label retinal pigment epithelial cell
Description An epithelial cell of the retinal pigmented epithelium.


Recruitment Status Completed