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NCT02592330 · ClinicalTrials.gov registry record · Phase 1
Limbal Stem Cell Deficiency (LSCD) Treatment With Cultivated Stem Cell (CALEC) Graft
A Phase 1 study of Limbal Stem Cell Deficiency, sponsored by Massachusetts Eye and Ear Infirmary.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT02592330: Completed Phase 1 study of Limbal Stem Cell Deficiency, sponsored by Massachusetts Eye and Ear Infirmary.
NCT02592330 is a Phase 1 study of Limbal Stem Cell Deficiency that has completed, run by Massachusetts Eye and Ear Infirmary. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02592330, a Phase 1 study of Limbal Stem Cell Deficiency, has completed, sponsored by Massachusetts Eye and Ear Infirmary.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
The main aim of the study is to determine the safety and feasibility of a cultivated autologous limbal epithelial cell (CALEC) transplantation in the treatment of limbal stem cell deficiency.
Primary Outcome
The occurrence of the following adverse events at any time during the 18 months of follow-up in the recipient eye will serve as the primary safety events of interest. 1. Ocular Infection (defined as endophthalmitis or microbial keratitis \[bacterial, fungal, parasitic\]: 2. Corneal Perforation 3. Graft Detachment ≥50%
Conditions Studied
Interventions
- PROCEDURE Biopsy to collect limbal epithelial stem cells that will be cultivated into a graft
- BIOLOGICAL Cultivation of Limbal epithelial cells into a graft
- PROCEDURE CALEC Transplant
Study Locations (1)
Massachusetts
- Massachusetts Eye and Ear Infirmary - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2016-08-01 |
| Est. Completion | 2023-03-31 |
| Phase | Phase 1 |
What the finished NCT02592330 record still lists
NCT02592330 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Limbal Stem Cell Deficiency appearing as the primary indexed condition, and to 3 interventions - of which Biopsy to collect limbal epithelial stem cells that will be cultivated into a graft is the first listed.
NCT02592330 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02592330 about?
NCT02592330 is a clinical study titled "Limbal Stem Cell Deficiency (LSCD) Treatment With Cultivated Stem Cell (CALEC) Graft". The main aim of the study is to determine the safety and feasibility of a cultivated autologous limbal epithelial cell (CALEC) transplantation in the treatment of limbal stem cell deficiency.
What is the current status of trial NCT02592330?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2016-08-01. Estimated completion is 2023-03-31.
What conditions does trial NCT02592330 study?
This clinical trial studies the following conditions: Limbal Stem Cell Deficiency.
What interventions are being tested in trial NCT02592330?
The interventions under investigation include: Biopsy to collect limbal epithelial stem cells that will be cultivated into a graft (PROCEDURE), Cultivation of Limbal epithelial cells into a graft (BIOLOGICAL), CALEC Transplant (PROCEDURE).
Who is sponsoring clinical trial NCT02592330?
This trial is sponsored by Massachusetts Eye and Ear Infirmary, which has 73 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02592330 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02592330's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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