drugset / Trial / NCT03544632

Acellular Adipose Tissue (AAT) for Soft Tissue Reconstruction

NCT03544632 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-06-21
Primary completion
2026-02-28
Completion
2026-02-28

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Acellular Adipose Tissue (AAT) Other / unclassified 5 ml Subcutaneous
Subject Acellular Adipose Tissue (AAT) Other / unclassified 20 ml Subcutaneous

Indications

No indication recorded.