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NCT04723303 · ClinicalTrials.gov registry record · Early Phase 1
Phase 1 Study of ULSC in Patients With Polymyositis (PM) and Dermatomyositis (DM)
A Early Phase 1 study, sponsored by University of Florida.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT04723303: Completed Early Phase 1 study, sponsored by University of Florida.
NCT04723303 is a Early Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 10 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04723303, a Early Phase 1 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study will investigate Umbilical Cord Lining Stem Cells (ULSC) as an investigational medicinal product and its use in patients with polymyositis (PM) or dermatomyositis (DM) to see if a single intravenous (IV) infusion of allogeneic umbilical cord lining stem cells (ULSC) safe, tolerable, and feasible to administer.
Primary Outcome
Dose Limiting Toxicities are treatment-emergent suspected adverse reactions graded severe, such as severe infusion-related hypersensitivity toxicities of grade ≥3, and any serious adverse event (SAE). (Note: DLT during an infusion will stop that infusion in that subject.)
Interventions
- DRUG Umbilical Cord Lining Stem Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-10-06 |
| Est. Completion | 2024-03-08 |
| Phase | Early Phase 1 |
What the finished NCT04723303 record still lists
NCT04723303 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Umbilical Cord Lining Stem Cells is the first listed.
NCT04723303 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04723303 about?
NCT04723303 is a clinical study titled "Phase 1 Study of ULSC in Patients With Polymyositis (PM) and Dermatomyositis (DM)". This study will investigate Umbilical Cord Lining Stem Cells (ULSC) as an investigational medicinal product and its use in patients with polymyositis (PM) or dermatomyositis (DM) to see if a single intravenous (IV) infusion of allogeneic umbilical cord lining stem cells (ULSC) safe, tolerable, and f...
What is the current status of trial NCT04723303?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2021-10-06. Estimated completion is 2024-03-08.
What interventions are being tested in trial NCT04723303?
The interventions under investigation include: Umbilical Cord Lining Stem Cells (DRUG).
Who is sponsoring clinical trial NCT04723303?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04723303's enrollment target sits among peer trials
10 1629th of 2000 higher than 256 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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