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NCT06489028 · ClinicalTrials.gov registry record · Phase 3
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III)
A Phase 3 study of Venous Leg Ulcer, sponsored by RHEACELL GmbH & Co. KG.
- Active
- Registry status
- Phase 3
- Development phase
- 250
- Enrollment target
- 15
- Study locations
NCT06489028: Active Phase 3 study of Venous Leg Ulcer, sponsored by RHEACELL GmbH & Co. KG.
NCT06489028 is a Phase 3 study of Venous Leg Ulcer that is active but no longer recruiting, run by RHEACELL GmbH & Co. KG. The registered enrollment target is 250 participants, roughly in line with the 238-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target. The trial reports 15 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06489028, a Phase 3 study of Venous Leg Ulcer, is active but no longer recruiting, sponsored by RHEACELL GmbH & Co. KG.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 250 participants
- Enrollment target
- 15
- Study locations
Study Summary
The aim of this clinical trial is to investigate the efficacy and safety of allo-APZ2-CVU, administered topically on therapy-resistant non-healing CVUs compared to placebo.
Primary Outcome
Complete wound closure already persisting for at least two weeks
Conditions Studied
Interventions
- DRUG Placebo
- DRUG allo-APZ2-CVU
Study Locations (15)
Other
- RHEACELL Clinical Trial Site - Multiple Locations
- RHEACELL Clinical Trial Site - Multiple Locations
- RHEACELL Clinical Trial Site - Multiple Locations
- RHEACELL Clinical Trial Site - Several Locations
- RHEACELL Clinical Trial Site - Multiple Locations
- RHEACELL Clinical Trial Site - Multiple Locations
- RHEACELL Clinical Trial Site - Multiple Locations
- RHEACELL Clinical Trial Site - Multiple Locations
- RHEACELL Clinical Trial Site - Multiple Locations
- RHEACELL Clinical Trial Site - Multiple Locations
- RHEACELL Clinical Trial Site - Multiple Locations
Florida
- RHEACELL Clinical Trial Site - Hialeah
- RHEACELL Clinical Trial Site - Miami
Massachusetts
- RHEACELL Clinical Trial Site - Boston
Minnesota
- RHEACELL Clinical Trial Site - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2024-12-26 |
| Est. Completion | 2027-09 |
| Phase | Phase 3 |
What the registry record for NCT06489028 still lists
NCT06489028 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 238-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target.
The record links to 1 condition, with Venous Leg Ulcer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06489028 lists 15 locations in 4 states (Other, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT06489028 about?
NCT06489028 is a clinical study titled "Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III)". The aim of this clinical trial is to investigate the efficacy and safety of allo-APZ2-CVU, administered topically on therapy-resistant non-healing CVUs compared to placebo.
What is the current status of trial NCT06489028?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2024-12-26. Estimated completion is 2027-09.
What conditions does trial NCT06489028 study?
This clinical trial studies the following conditions: Venous Leg Ulcer.
What interventions are being tested in trial NCT06489028?
The interventions under investigation include: Placebo (DRUG), allo-APZ2-CVU (DRUG).
Who is sponsoring clinical trial NCT06489028?
This trial is sponsored by RHEACELL GmbH & Co. KG, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06489028 being conducted?
This trial has 15 study locations across Florida, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Venous Leg Ulcer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06489028's enrollment target sits among peer trials
250 10th of 35 higher than 26 of 35 other Venous Leg Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Venous Leg Ulcer 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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