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 |
| Link |
http://purl.obolibrary.org/obo/DOID_4448 |
| 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. |
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| Publications |
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Administrative Information |
| NCT number |
NCT02903576 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=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 |
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| 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 |
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| Sponsors |
Federal University of São Paulo
|
Cells |
| Source pluripotent stem cell lines |
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| Which differentiated cell type is used |
| Label |
retinal pigment epithelial cell |
| Link |
http://purl.obolibrary.org/obo/CL_0002586 |
| Description |
An epithelial cell of the retinal pigmented epithelium. |
|
Recruitment |
| Recruitment Status |
Completed |
