Stem Cell Therapy for Outer Retinal Degenerations
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|ClinicalTrials.gov Identifier: NCT02903576|
Recruitment Status : Unknown
Verified August 2017 by Rubens Belfort Jr., Federal University of São Paulo.
Recruitment status was: Recruiting
First Posted : September 16, 2016
Last Update Posted : August 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Age Related Macular Degeneration Stargardt's Disease Exudative Age-related Macular Degeneration||Procedure: injection of hESC-RPE in suspension Procedure: injection hESC-RPE seeded in a substrate||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stem Cell Derived Retinal Pigmented Epithelium Implantation in Patients With Outer Retinal Degenerations: Phase I/II Clinical Trial|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2019|
Active Comparator: injection of hESC-RPE in suspension
6 patients will receive cell suspension injections on the sub retinal space prior to the surgeries, to access safety
Procedure: injection of hESC-RPE in suspension
The first six patients will receive a sub retinal injection of hESC-RPE in solution after a complete pars plana vitrectomy to access safety of the cell implant alone.
Other Name: Human Embryonic Stem Cell - Retinal Pigmented Epithelium
Active Comparator: injection hESC-RPE seeded in a substrate
15 patients will receive a sub-retinal implantation of a polymeric scaffold seeded hesc- RPE in monolayer
Procedure: injection hESC-RPE seeded in a substrate
Fifteen patients will receive a sub-retinal implantation of embryonic stem cell derived retinal pigmented epithelium seeded in a polymeric substrate to access safety of substrate seeded with RPE
Other Name: Human Embryonic Stem Cell seeded in a polymeric substrate
- Incidence of Treatment-Emergent Adverse Events of sub retinal implantation of stem cell derived retinal pigmented epithelium in the sub retinal space. [ Time Frame: 1 year ]Incidence of surgical related side effects: Retinal detachment, Ocular inflammation, Increase in intraocular pressure, Infection( endophthalmitis), Loss of vision due to surgical, related complications
- Incidence of side effects related to the treatment itself( injection and implantation of sub retinal stem cell related RPE) [ Time Frame: 1 year ]Inflammation/rejection Cell migration/differentiation Tumor formation Proliferative vitreoretinopathy/Retinal detachment Implant migration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02903576
|Contact: Rodrigo AB Fernandes, MDemail@example.com|
|Federal University of Sao Paulo||Recruiting|
|Sao Paulo, Brazil, 04023-062|
|Contact: Rodrigo AB Fernandes, MD +5511972456473 firstname.lastname@example.org|
|Study Chair:||Rubens Belfort, MD||Federal University of São Paulo (UNIFESP)|