Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02445612 · ClinicalTrials.gov registry record
Long Term Follow Up of Sub-retinal Transplantation of hESC Derived RPE Cells in Stargardt Macular Dystrophy Patients
A clinical trial of Stargardt's Macular Dystrophy, sponsored by Astellas Institute for Regenerative Medicine.
- Completed
- Registry status
- 13
- Enrollment target
- 3
- Study locations
NCT02445612: Completed study of Stargardt's Macular Dystrophy, sponsored by Astellas Institute for Regenerative Medicine.
NCT02445612 is a study of Stargardt's Macular Dystrophy that has completed, run by Astellas Institute for Regenerative Medicine. The registered enrollment target is 13 participants. The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02445612, a study of Stargardt's Macular Dystrophy, has completed, sponsored by Astellas Institute for Regenerative Medicine.
- COMPLETED
- Registry status
- 13 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to evaluate the long term safety and tolerability of MA09-hRPE cellular therapy in patients with advanced Stargardt's Macular Dystrophy (SMD) from one to five years following the surgical procedure to implant the MA09-hRPE cells.
Primary Outcome
This will include obtaining information about ophthalmological findings and Serious Adverse Events (SAEs) that are neurologic, infectious, hematologic or fatal, pregnancy in a female subject or the partner of a male subject and pregnancy outcome, any adverse event (AE) that causes a subject to withdraw from the study, any new diagnosis of an ocular or immune-mediated disorder, cancer, ectopic or proliferative cell growth (Retinal pigment epithelium (RPE) or non-RPE) with adverse clinical consequ
Conditions Studied
Interventions
- BIOLOGICAL MA09-hRPE
Study Locations (3)
California
- Jules Stein Eye Institute, UCLA School of Medicine - Los Angeles
Florida
- Bascom Palmer Eye Institute - Miami
Pennsylvania
- Wills Eye Institute-Mid Atlantic Retina - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2012-07-11 |
| Est. Completion | 2019-06-21 |
What the finished NCT02445612 record still lists
NCT02445612 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 13 participants, a relatively small participant target.
The record links to 1 condition, with Stargardt's Macular Dystrophy appearing as the primary indexed condition, and to 1 intervention - of which MA09-hRPE is the first listed.
NCT02445612 reports a single indexed study location in California, Florida, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02445612 about?
NCT02445612 is a clinical study titled "Long Term Follow Up of Sub-retinal Transplantation of hESC Derived RPE Cells in Stargardt Macular Dystrophy Patients". The purpose of this study is to evaluate the long term safety and tolerability of MA09-hRPE cellular therapy in patients with advanced Stargardt's Macular Dystrophy (SMD) from one to five years following the surgical procedure to implant the MA09-hRPE cells.
What is the current status of trial NCT02445612?
This trial is currently completed. The enrollment target is 13 participants. The study started on 2012-07-11. Estimated completion is 2019-06-21.
What conditions does trial NCT02445612 study?
This clinical trial studies the following conditions: Stargardt's Macular Dystrophy.
What interventions are being tested in trial NCT02445612?
The interventions under investigation include: MA09-hRPE (BIOLOGICAL).
Who is sponsoring clinical trial NCT02445612?
This trial is sponsored by Astellas Institute for Regenerative Medicine, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02445612 being conducted?
This trial has 3 study locations across California, Florida, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03125655 · 13 participants
Regulation of Inflammatory Genes in Psoriasis
- NCT03774446 · 13 participants · Phase 2
Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease
- NCT03830151 · 13 participants · Phase 1
Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors
- NCT04573231 · 13 participants · Phase 2
Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI