Age Related Macular Degeneration Clinical Trial
Official title:
Stem Cell Derived Retinal Pigmented Epithelium Implantation in Patients With Outer Retinal Degenerations: Phase I/II Clinical Trial
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,
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.
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