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NCT04626583 · ClinicalTrials.gov registry record · Phase 1
Safety of Locally Delivered Allogeneic Mesenchymal Stromal Cells
A Phase 1 study, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT04626583: Completed Phase 1 study, sponsored by University of Illinois at Chicago.
NCT04626583 is a Phase 1 study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04626583, a Phase 1 study, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This study is a longitudinal assessment using a classic dose-escalation study design to assess the safety and maximal tolerated dose (MTD) of locally delivered allogeneic mesenchymal stromal cells (MSC) for promoting corneal repair. The study will be conducted at Illinois Eye and Ear Infirmary located at University of Illinois at Chicago. The study will use digital conjunctival and corneal photography and corneal Scheimpflug Imaging, densitometry, and pachymetry for assessment of safety and corneal wound healing.
Primary Outcome
Slit lamp exam will assess the safety of the treatment via TEAE at 28 days (participants will receive continued monitoring through 90 days). TEAE will be defined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5) adverse event reference, and used to identify dose-limiting toxicity (DLT). The DLT will be defined as any non-corneal, ocular or systemic TEAE, with a Grade 2 toxicity without resolution after 14 days OR a Grade 3 toxicity, unles
Interventions
- BIOLOGICAL Allogeneic MSC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-03-05 |
| Est. Completion | 2023-04-21 |
| Phase | Phase 1 |
What the finished NCT04626583 record still lists
NCT04626583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Allogeneic MSC is the first listed.
NCT04626583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04626583 about?
NCT04626583 is a clinical study titled "Safety of Locally Delivered Allogeneic Mesenchymal Stromal Cells". This study is a longitudinal assessment using a classic dose-escalation study design to assess the safety and maximal tolerated dose (MTD) of locally delivered allogeneic mesenchymal stromal cells (MSC) for promoting corneal repair. The study will be conducted at Illinois Eye and Ear Infirmary locat...
What is the current status of trial NCT04626583?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2021-03-05. Estimated completion is 2023-04-21.
What interventions are being tested in trial NCT04626583?
The interventions under investigation include: Allogeneic MSC (BIOLOGICAL).
Who is sponsoring clinical trial NCT04626583?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04626583's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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