Healthy Volunteers Clinical Trial
Official title:
A Phase I Open-label Study Evaluating the Safety of Acellular Adipose Tissue (AAT), a Novel Soft Tissue Reconstruction Solution, in Healthy Volunteers
The purpose of this study is to assess the safety and tolerability of acellular adipose tissue (AAT), intended for the repair of soft tissue defects in humans, in healthy volunteers. The investigators hypothesize that AAT will be safe and well tolerated upon injection into human soft tissue.
This is a 12-week, prospective, Phase I study in healthy volunteers assessing the safety and
tolerability of acellular adipose tissue (AAT) intended for the repair of soft tissue defects
in humans. Up to five (5) 2 milliliters (mL) subcutaneous injections of AAT will be
administered into redundant tissues previously identified and scheduled for surgical removal
in an elective surgical procedure.
Participants will be enrolled and assigned chronologically to one of five excision time
points: Weeks 2, 4, 6, 8, and 12 post-injection. Implants will be injected on Day 0. A safety
visit will occur at 1 week post-injection; follow-up visits will occur at Weeks 2 and 4 (for
patients who still have implants) post-injection and at time of tissue excision. At the end
of their assigned study time point, participants will have all AAT implants removed
simultaneously during their elective surgery. Implants will be assessed using
histopathological analyses including hematoxylin and eosin staining and flow cytometry. The
primary outcome of safety will be determined by the incidence and rate of adverse /
unanticipated events. Secondary outcomes include histopathological assessment of the
explanted implants and tolerability determined by participant-reported comfort and
physician-reported ease-of-use with the intervention.
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