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NCT03544632 · ClinicalTrials.gov registry record · Phase 2
Acellular Adipose Tissue (AAT) for Soft Tissue Reconstruction
A Phase 2 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT03544632: Completed Phase 2 study, sponsored by Johns Hopkins University.
NCT03544632 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03544632, a Phase 2 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
Although other methods (e.g., autologous fat transfer, dermal-/collagen-based fillers) for soft tissue reconstruction exist, each has distinct disadvantages leaving room for improvement in this treatment area. Investigators in the Elisseeff Laboratory (Johns Hopkins University Department of Biomedical Engineering) have recently generated a novel tissue-derived material to create instructive matrices for soft tissue reconstruction called Acellular Adipose Tissue (AAT). This material takes advantage of the inherent bioactivity and unique mechanical properties of subcutaneous adipose tissue. Investigators' preclinical data suggest that AAT is safe for use in small and large animals; investigators' clinical (Phase I) data suggest that AAT is safe for use in humans. These data indicate that a Phase II, dose-escalation study of AAT's safety and efficacy in human subjects is warranted.
Primary Outcome
Volume retention documented by pre-to-post injection volumetric changes as detected by 3-dimensional photography
Interventions
- DRUG Acellular Adipose Tissue (AAT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-06-21 |
| Est. Completion | 2026-02-28 |
| Phase | Phase 2 |
What the finished NCT03544632 record still lists
NCT03544632 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Acellular Adipose Tissue (AAT) is the first listed.
NCT03544632 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03544632 about?
NCT03544632 is a clinical study titled "Acellular Adipose Tissue (AAT) for Soft Tissue Reconstruction". Although other methods (e.g., autologous fat transfer, dermal-/collagen-based fillers) for soft tissue reconstruction exist, each has distinct disadvantages leaving room for improvement in this treatment area. Investigators in the Elisseeff Laboratory (Johns Hopkins University Department of Biomedic...
What is the current status of trial NCT03544632?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2018-06-21. Estimated completion is 2026-02-28.
What interventions are being tested in trial NCT03544632?
The interventions under investigation include: Acellular Adipose Tissue (AAT) (DRUG).
Who is sponsoring clinical trial NCT03544632?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03544632's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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