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 |
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| 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.; This extended description was generated by ChatGPT and reviewed by the CellGuide team, who added references, and by the CL editors, who approved it for inclusion in CL. It may contain information that applies to only to some subtypes and species, and so should not be considered definitional.
Retinal pigment epithelial (RPE) cells form a single layer of cells at the back of the eye sandwiched between the neurosensory retina and the choroid, playing a significant role in maintaining vision health. These pigment-laden cells are highly specialized and perform an array of metabolic and transport functions essential for the maintenance of the photoreceptor cells (rods and cones) in the retina. The pigmentation of RPE cells actively aids in the absorption of excess light and the prevention of light scattering, thus enhancing the eye's optical properties.
The retinal pigment epithelium forms a key part of the blood/retina barrier. The cells have long sheet-like microvilli on their apical membrane that project into the light-sensitive outer segments of the photoreceptors, forming a close structural interaction. The basolateral membrane of the RPE interacts with the underlying Bruch’s membrane, which separates the RPE cells from fenestrated endothelium of the choriocapillaris.
RPE cells support the photoreceptor by providing them with oxygen and nutrients (such as glucose, retinol and fatty acids) and removing waste products. They also recycle the visual pigment, in a process called the "visual cycle", where the RPE cells play a vital role in the regeneration of visual pigment (11-cis retinol) following the absorption of light. This is essential for the maintenance of photoreceptor excitability.
Beyond this, RPE cells take part in the phagocytosis process, where they digest the shed ends of photoreceptor outer segments, thus, preventing the build-up of waste residue that could otherwise harm retinal health. They also secrete various factors, including growth factors required to maintain the structural integrity of choriocapillaris endothelium and photoreceptors, as well as immunosuppressive factors that play an important role in establishing the immune privilege of the eye. |
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Recruitment |
| Recruitment Status |
Completed |
