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NCT01344993 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of Sub-retinal Transplantation of hESC Derived RPE (MA09-hRPE) Cells in Patients With Advanced Dry Age Related Macular Degeneration
A Phase 1 study, sponsored by Astellas Institute for Regenerative Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01344993: Completed Phase 1 study, sponsored by Astellas Institute for Regenerative Medicine.
NCT01344993 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
NCT01344993, 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 dry Age Related Macular Degeneration (AMD) and to perform exploratory evaluation of potential efficacy endpoints to be used in future studies retinal pigment epithelium (RPE) cellular therapy.
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 | 2011-06-09 |
| Est. Completion | 2015-08-19 |
| Phase | Phase 1 |
What the finished NCT01344993 record still lists
NCT01344993 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.
NCT01344993 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01344993 about?
NCT01344993 is a clinical study titled "Safety and Tolerability of Sub-retinal Transplantation of hESC Derived RPE (MA09-hRPE) Cells in Patients With Advanced Dry Age Related Macular Degeneration". 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 dry Age Related Macular Degeneration (AMD) and to perform exploratory evaluation of potential efficacy endpoints to be used in...
What is the current status of trial NCT01344993?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2011-06-09. Estimated completion is 2015-08-19.
What interventions are being tested in trial NCT01344993?
The interventions under investigation include: MA09-hRPE (BIOLOGICAL).
Who is sponsoring clinical trial NCT01344993?
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 NCT01344993'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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