Acellular Adipose Tissue (AAT) for Soft Tissue Reconstruction
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|ClinicalTrials.gov Identifier: NCT03544632|
Recruitment Status : Recruiting
First Posted : June 4, 2018
Last Update Posted : July 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Injuries Trauma||Drug: Acellular Adipose Tissue (AAT)||Phase 2|
Soft tissue volume loss acquired through trauma, congenital malformation or comorbid conditions (i.e., HIV/AIDS) is a common and sometimes devastating problem. Traditional therapies include local tissue transfer, allograft placement, and complex scar revision techniques. Recently, autologous fat transfer has become one of the most commonly employed techniques for improving soft tissue contour deformity particularly for the correction of breast and body defects. While the results from this procedure continue to improve, it requires an additional procedure to harvest fat tissue from the abdomen, thigh or flank leading to donor site morbidity. Clinically, volume loss following autologous fat transfer has been reported to be between 40-60% and usually occurs within the first 4-6 months. Regrafting is often needed and implanted adipose tissue frequently leads to post-operative calcifications. For these reasons, a predictable, "off-the-shelf" material that retains the mechanical and biological properties of adipose tissue would be ideal for the reconstruction of smaller soft tissue defects and soft tissue augmentation.
Investigators in the Elisseeff Laboratory (Johns Hopkins University Department of Biomedical Engineering) generated a novel tissue-derived material to create instructive matrices for soft tissue reconstruction [Acellular Adipose Tissue (AAT)]. In 2016, investigators conducted a Phase 1, open-label, clinical trial of AAT in healthy volunteers who planned to have elective surgery for the removal of redundant tissue (n=8). Overall, AAT demonstrated satisfactory safety results. No participants experienced serious adverse events (SAEs) or unanticipated adverse events (AEs) related to the study, or exited the study due to AEs. All AEs noted were expected and mild, including redness, bruising, textural changes, hyperpigmentation and tenderness at the injection site. Many other adverse events commonly associated with injections were not observed in any participant throughout the study (i.e., scarring, ulceration, scabbing, purpura, oozing, crusting, blanching, blistering, edema or abrasions). These data indicate that conducting a phase II, dose-escalation, safety and efficacy study in humans is warranted. Based on investigators' experience, investigators hypothesize that AAT will be safe and maintain its volume up to 6 months when injected subcutaneously to restore 5-20cc defects in human soft tissue.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Dose-escalation, Open-label Study Evaluating the Safety and Efficacy of Permanently-placed Acellular Adipose Tissue (AAT) in Human Subjects With Modest Soft Tissue Defects of the Trunk|
|Actual Study Start Date :||June 21, 2018|
|Estimated Primary Completion Date :||December 7, 2019|
|Estimated Study Completion Date :||June 7, 2020|
Experimental: Acellular Adipose Tissue (AAT)
This open-label, phase II, dose-escalation study will be conducted in human subjects seeking repair of modest (approx. 5-30cc) soft tissue defects of the trunk (n=15). All participants will be treated via permanent injection of the study intervention (AAT injection) to restore the defect's contour. All study data will be collected in Case Report Forms (CRFs) and entered into a customized study database, created and maintained in HIPAA-compliant Research Electronic Data Capture (REDCap) software (14).
Drug: Acellular Adipose Tissue (AAT)
Participants (n=15) will be administered between 5cc and 20cc of AAT, depending on their assigned treatment group, via sterile subcutaneous injection into the target defect. The injection is intended to be permanent. After the 3-month study follow-up visit, participants will have the option to undergo additional AAT injection (up to 20cc per treatment) in order to fully correct the defect. Total injected AAT volume per patient will not exceed 40cc. Additional injection is dependent upon study- and patient-specific adverse / unanticipated events to date.
Each vial contains a 2 milliliter (mL) dose of the injectable AAT. This volume is similar to other commonly used injectable filler materials intended for soft tissue correction.
- AAT efficacy for soft-tissue reconstruction in humans to restore volume in soft tissue defects of the trunk [ Time Frame: 6 months post-final injection ]Volume retention documented by pre-to-post injection volumetric changes as detected by 3-dimensional photography
- AAT efficacy for soft-tissue reconstruction in humans to restore volume in soft tissue defects of the trunk [ Time Frame: 6 months post-final injection ]Assessments to determine aesthetic appearance of defects documented by blinded assessors rating defect sites using the Global Aesthetic Improvement Scale (GAIS)
- AAT efficacy for soft-tissue reconstruction in humans to restore volume in soft tissue defects of the trunk [ Time Frame: 6 months post-final injection ]Post-injection assessment to determine aesthetic outcome documented by patient-reported satisfaction with the repair
- Histopathological analysis of explanted implants [ Time Frame: up to 12 months post-injection ]Histopathology will be performed on core needle biopsy samples collected at 3, 6, 9, and 12 months post-injection and will be done using the following: H&E staining to assess (1) native cellular infiltration of the implant, (2) location of implant relative to dermis/subdermis, (3) inflammatory response to implant, and (4) presence of fibrosis
- Physician Ease of Use Assessments [ Time Frame: up to 12 months post-injection ]Physician ease of use will be measured through the completion of self-administered surveys by the study surgeon.
- Participant Comfort Surveys [ Time Frame: up to 12 months post-injection ]Participant comfort will be measured through the completion of self-administered surveys by the participant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03544632
|Contact: Carisa Cooney, MPHfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins University School of Medicine||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Carisa M Cooney, MPH 443-287-4629 email@example.com|
|Contact: Jordan Garcia, MD firstname.lastname@example.org|
|Principal Investigator:||Damon Cooney, MD, PhD||The Department of Plastic and Reconstructive Surgery, Johns Hopkins University School of Medicine|