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NCT01564407 · ClinicalTrials.gov registry record · Phase 1
A Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures
A Phase 1 study, sponsored by University of Pittsburgh.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT01564407: Clinical Trial Phase 1 study, sponsored by University of Pittsburgh.
NCT01564407 is a Phase 1 study that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01564407, a Phase 1 study, was terminated before completion, sponsored by University of Pittsburgh.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the safety of ICX-RHY-013 in the treatment of stable, restrictive scars in subjects who have suffered a burn injury. Evaluation will be achieved through regular assessment of adverse events, vital signs, blood work monitoring and laboratory analysis cellular properties of the scar through biopsy. The secondary objectives of this study are to evaluate improvement in symptoms of scars including reduced pain, discomfort and itching, improvement in mobility and daily function, improvement in appearance and scar texture.
Primary Outcome
The evaluation of safety of ICX-RHY-013 in the treatment of stable, restrictive hypertrophic scars through assessment of adverse events. The primary objective of the safety (no injection) cohort is to evaluate initial safety of multiple doses through assessment of adverse events. The primary objective of remaining cohorts is to evaluate the ongoing safety of ICX-RHY-013 in post-burn hypertrophic scars that are not planned for excision through assessment of adverse events.
Interventions
- DRUG ICX-RHY-013
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2011-01 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
Why NCT01564407 stopped before completion
NCT01564407 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which ICX-RHY-013 is the first listed.
NCT01564407 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01564407 about?
NCT01564407 is a clinical study titled "A Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures". The primary objective of this study is to evaluate the safety of ICX-RHY-013 in the treatment of stable, restrictive scars in subjects who have suffered a burn injury. Evaluation will be achieved through regular assessment of adverse events, vital signs, blood work monitoring and laboratory analysis...
What is the current status of trial NCT01564407?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2011-01. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01564407?
The interventions under investigation include: ICX-RHY-013 (DRUG).
Who is sponsoring clinical trial NCT01564407?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01564407's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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