Sub-retinal Transplantation of hESC Derived RPE(MA09-hRPE)Cells in Patients With Stargardt's Macular Dystrophy
NCT01345006 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2024-10-31
Summary
This is a safety and tolerability trial to evaluate the effect of subretinal injection of human embryonic stem cell derived retinal pigment epithelium cells in patients with Stargardt's Macular Dystrophy (SMD).
Conditions
- Stargardt's Macular Dystrophy
Interventions
- BIOLOGICAL
-
MA09-hRPE
Cohort 1 50,000 cells Cohort 2 100,000 cells Cohort 2a Better Vision 100,000 cells Cohort 3 150,000 cells Cohort 4 200,000 cells
Sponsors & Collaborators
-
Astellas Institute for Regenerative Medicine
lead INDUSTRY
Principal Investigators
-
Medical Director · Astellas Institute for Regenerative Medicine
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-06-16
- Primary Completion
- 2015-08-10
- Completion
- 2015-08-10
Countries
- United States
Study Locations
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