Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2015-08-31
2019-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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.
injection hESC-RPE seeded in a substrate
15 patients will receive a sub-retinal implantation of a polymeric scaffold seeded hesc- RPE in monolayer
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
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with Stargardt's Disease BCVA on the selected eye: worse than 20/200
Exclusion Criteria
* Systemic diseases with contraindication for surgical procedures with local anaesthesia
18 Years
90 Years
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Rubens Belfort Jr.
Full Professor of Ophthalmology
Principal Investigators
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Rubens Belfort, MD
Role: STUDY_CHAIR
Federal University of São Paulo UNIFESP
Locations
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Federal University of Sao Paulo
São Paulo, , Brazil
Countries
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Other Identifiers
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12018712.5.0000.5505
Identifier Type: -
Identifier Source: org_study_id
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