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) 2019-06-01
Clinical feature
Label Stargardt Disease
Link http://purl.obolibrary.org/obo/NCIT_C85078
Description An autosomal recessive and rarely autosomal dominant inherited disorder caused by mutations in the ABCA4 or ELOVL4 genes respectively. It is characterized by macular degeneration that begins in late childhood resulting in progressive loss of vision.

Administrative Information

NCT Number NCT02903576
Other study identifiers
Name 12018712.5.0000.5505
Source weblink https://clinicaltrials.gov/ct2/show/NCT02903576
Regulatory body approval
Name National Committee of Ethics in Research
Country
Brazil
Public contact
Email rodrigo.brant@ophthal.com.br
Public email rodrigo.brant@ophthal.com.br
First name Rodrigo AB
Last name Fernandes
Phone +5511972456473
Country
Brazil
Sponsors Federal University of São Paulo (UNIFESP)

Cell Line

Stem cell lines obtained from

Recruitment

Recruitment Status Recruiting
Estimated number of participants 18