Stem Cell Therapy for Outer Retinal Degenerations
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|ClinicalTrials.gov Identifier: NCT02903576|
Recruitment Status : 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
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)|