A Phase 1 interventional study of Acellular Adipose Tissue (AAT) in Healthy Volunteers, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-25.
Sponsored by Johns Hopkins University · Phase 1, Interventional, and Other
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.
Johns Hopkins University is the lead sponsor of 1,809 studies on the registry; 314 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Men and Women of reproductive potential: Willingness to use approved methods of birth control or abstain from sexual intercourse from screening until removal of the AAT implants.
Exclusion Criteria:
Use of AAT in patients exhibiting autoimmune connective tissue disease is not recommended. When applied properly, AAT has been shown to support the migration of host cells from the surrounding tissue. Therefore, this study will exclude patients with conditions that could inhibit migration of host cells including, but not limited to, the following:
Participants (n=10) will be enrolled and assigned chronologically to one of five excision time points: Weeks 2 (n=10), 4 (n=2), 6 (n=2), 8 (n=2), and 12 (n=2) post-injection. Implants will be injected on Day 0. All participants will be administered up to five (5) 2 milliliter (mL) subcutaneous injections of acellular adipose tissue (AAT) via sterile injection into the area identified for planned excision. Total injected AAT volume per patient will not exceed 10 mL.
Biological: Acellular Adipose Tissue (AAT)
The components of the adipose-derived scaffold are all naturally occurring AAT proteins and proteoglycans that provide a natural scaffold. The nature of the AAT also enhances host tissue integration since matrix components can be easily degraded by cell-secreted enzymes as tissue remodeling takes place. Mechanisms for matrix turnover are already established in host cells, avoiding any concerns over proper clearance of scaffold materials from the body.
Safety of acellular adipose tissue (AAT) injections as determined by the incidence of adverse events
Time frame: Up to 12 weeks post-injection
Safety of acellular adipose tissue (AAT) injections as determined by the rate of adverse events
Time frame: Up to 12 weeks post-injection
Assess the histopathology of explanted implants via Hematoxylin and eosin (H&E) staining
Time frame: Up to 12 weeks post-injection
Assess the histopathology of explanted implants via flow cytometry
Flow cytometry via fluorescence-activated cell sorting (FACS)
Time frame: Up to 12 weeks post-injection
Assess tolerability of AAT injections per the participant-reported experience.
Tolerability of AAT injections is assessed through participant-reported comfort questionnaire.
Time frame: Up to 12 weeks post-injection
Assess tolerability of AAT injections per the physician-reported experience.
Tolerability of AAT injections is assessed through physician-reported ease-of-use with the intervention (questionnaire).
Time frame: Up to 12 weeks post-injection
Plan to share: Yes
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.