Stem Cell Therapy for Outer Retinal Degenerations
Stem Cell Derived Retinal Pigmented Epithelium Implantation in Patients With Outer Retinal Degenerations: Phase I/II Clinical Trial
1 other identifier
interventional
15
1 country
1
Brief 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,
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2015
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 7, 2016
CompletedFirst Posted
Study publicly available on registry
September 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedJuly 22, 2020
August 1, 2017
3.4 years
March 7, 2016
July 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events of sub retinal implantation of stem cell derived retinal pigmented epithelium in the sub retinal space.
Incidence of surgical related side effects: Retinal detachment, Ocular inflammation, Increase in intraocular pressure, Infection( endophthalmitis), Loss of vision due to surgical, related complications
1 year
Secondary Outcomes (1)
Incidence of side effects related to the treatment itself( injection and implantation of sub retinal stem cell related RPE)
1 year
Study Arms (2)
injection of hESC-RPE in suspension
ACTIVE COMPARATOR6 patients will receive cell suspension injections on the sub retinal space prior to the surgeries, to access safety
injection hESC-RPE seeded in a substrate
ACTIVE COMPARATOR15 patients will receive a sub-retinal implantation of a polymeric scaffold seeded hesc- RPE in monolayer
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- Patients with AMD ( Dry , Wet after failure of treatment, disciform scars)
- Patients with Stargardt's Disease BCVA on the selected eye: worse than 20/200
You may not qualify if:
- Other ophthalmological diseases( Glaucoma, Diabetic Retinopathy, Previous retinal surgery, uveitis)
- Systemic diseases with contraindication for surgical procedures with local anaesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Sao Paulo
São Paulo, 04023-062, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rubens Belfort, MD
Federal University of São Paulo UNIFESP
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor of Ophthalmology
Study Record Dates
First Submitted
March 7, 2016
First Posted
September 16, 2016
Study Start
August 1, 2015
Primary Completion
January 1, 2019
Study Completion
June 1, 2019
Last Updated
July 22, 2020
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will share
scientific publication in a peer review journal