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NCT01345006 · ClinicalTrials.gov registry record · Phase 1
Sub-retinal Transplantation of hESC Derived RPE(MA09-hRPE)Cells in Patients With Stargardt's Macular Dystrophy
A Phase 1 study, sponsored by Astellas Institute for Regenerative Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01345006: Completed Phase 1 study, sponsored by Astellas Institute for Regenerative Medicine.
NCT01345006 is a Phase 1 study that has completed, run by Astellas Institute for Regenerative Medicine. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01345006, a Phase 1 study, has completed, sponsored by Astellas Institute for Regenerative Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study 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).
Primary Outcome
The transplantation of hESC-derived RPE cells MA09-hRPE will be considered safe and tolerated in the absence of: * Any grade 2 (NCI grading system) or greater adverse event related to the cell product * Any evidence that the cells are contaminated with an infectious agent * Any evidence that the cells show tumorigenic potential
Interventions
- BIOLOGICAL MA09-hRPE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2011-06-16 |
| Est. Completion | 2015-08-10 |
| Phase | Phase 1 |
What the finished NCT01345006 record still lists
NCT01345006 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which MA09-hRPE is the first listed.
NCT01345006 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01345006 about?
NCT01345006 is a clinical study titled "Sub-retinal Transplantation of hESC Derived RPE(MA09-hRPE)Cells in Patients With Stargardt's Macular Dystrophy". 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).
What is the current status of trial NCT01345006?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2011-06-16. Estimated completion is 2015-08-10.
What interventions are being tested in trial NCT01345006?
The interventions under investigation include: MA09-hRPE (BIOLOGICAL).
Who is sponsoring clinical trial NCT01345006?
This trial is sponsored by Astellas Institute for Regenerative Medicine, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01345006's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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