Acellular Adipose Tissue (AAT) for Soft Tissue Reconstruction

NCT03544632 | Enrolling By Invitation Phase 2 FDA Drug

• 1 other identifier: IRB00155003
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Soft Tissue Injuries; Trauma

Keywords

adipose-derived extracellular matrix (ECM); acellular adipose tissue (AAT)

Outcome Measures

Primary Outcomes (3)

• AAT efficacy for soft-tissue reconstruction - Volume Retention

  Volume retention documented by pre-to-post injection volumetric changes as detected by 3-dimensional photography

  6 months post-final injection

• AAT efficacy for soft-tissue reconstruction - blinded assessors

  Assessments to determine aesthetic appearance of defects documented by blinded assessors rating defect sites using the Global Aesthetic Improvement Scale (GAIS). 5 point scale ranging from 1 to 5 with 5 = The appearance has worsened compared with the original condition and 1 = Excellent corrective results

  6 months post-final injection

• AAT efficacy for soft-tissue reconstruction - patient-reported

  Post-injection assessment to determine aesthetic outcome documented by patient-reported satisfaction with the repair

  6 months post-final injection

Secondary Outcomes (3)

• Histopathological analysis of explanted implants

  up to 12 months post-injection

• Physician Ease of Use Assessments

  up to 12 months post-injection

• Participant Comfort Surveys

  up to 12 months post-injection

Study Arms (1)

Acellular Adipose Tissue (AAT)

EXPERIMENTAL

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)

Interventions

Acellular Adipose Tissue (AAT) DRUG

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.

Acellular Adipose Tissue (AAT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18-65 years with at least one modest (5-30cc) soft tissue defect on the trunk and
• Willingness to wait up to 6 months to participate in the study (depending on defect size and enrollment-to-date).
• Consent to photography for research purposes.
• Willingness to follow study requirements.
• Ability to give informed consent.
• Willingness to perform follow up visits for 12 months (+/- 30 days).
• Willingness to undergo complete blood count (CBC) with Differential and Serum Chemistry.
• For Men and Women of reproductive potential: Willingness to use approved methods of birth control or abstain from sexual intercourse from screening until 6 months post-AAT injection.
• Definition of non-childbearing potential for Women: amenorrhea (previous 12 months) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
• Definition of non-reproductive potential for Men: confirmed surgically sterile (vasectomy \>3 months prior to screening).

You may not qualify if:

• 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:
• Fever (oral temperature \>99º F at time of screening)
• Insulin dependent diabetes
• Low vascularity of the tissue intended for elective excision
• Local or Systemic Infection
• Mechanical Trauma
• Poor nutrition or general medical condition
• Dehiscence and/or necrosis due to poor revascularization
• Specific or nonspecific immune response to some component of the AAT material
• Infected or nonvascular surgical sites
• Known cancer or receiving treatment for cancer
• Also:
• Pregnant or Lactating females
• Inability to cooperate with and/or comprehend post-operative instructions
• Inability to speak or read English

Sponsors & Collaborators

• Johns Hopkins University: lead
• U.S. Army Medical Research and Development Command: collaborator
• Armed Forces Institute of Regenerative Medicine: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Related Publications (8)

• Bucky LP, Percec I. The science of autologous fat grafting: views on current and future approaches to neoadipogenesis. Aesthet Surg J. 2008 May-Jun;28(3):313-21; quiz 322-4. doi: 10.1016/j.asj.2008.02.004.

  PMID: 19083543 BACKGROUND

• Wan DC, Lim AT, Longaker MT. Craniofacial autologous fat transfer. J Craniofac Surg. 2009 Mar;20(2):273-4. doi: 10.1097/SCS.0b013e31819921d3. No abstract available.

  PMID: 19305242 BACKGROUND

• Cordeiro PG. Breast reconstruction after surgery for breast cancer. N Engl J Med. 2008 Oct 9;359(15):1590-601. doi: 10.1056/NEJMct0802899. No abstract available.

  PMID: 18843123 BACKGROUND

• Rosson GD, Magarakis M, Shridharani SM, Stapleton SM, Jacobs LK, Manahan MA, Flores JI. A review of the surgical management of breast cancer: plastic reconstructive techniques and timing implications. Ann Surg Oncol. 2010 Jul;17(7):1890-900. doi: 10.1245/s10434-010-0913-7. Epub 2010 Mar 9.

  PMID: 20217253 BACKGROUND

• Pulagam SR, Poulton T, Mamounas EP. Long-term clinical and radiologic results with autologous fat transplantation for breast augmentation: case reports and review of the literature. Breast J. 2006 Jan-Feb;12(1):63-5. doi: 10.1111/j.1075-122X.2006.00188.x.

  PMID: 16409589 BACKGROUND

• Cheng MH, Uriel S, Moya ML, Francis-Sedlak M, Wang R, Huang JJ, Chang SY, Brey EM. Dermis-derived hydrogels support adipogenesis in vivo. J Biomed Mater Res A. 2010 Mar 1;92(3):852-8. doi: 10.1002/jbm.a.32410.

  PMID: 19280638 BACKGROUND

• Uriel S, Huang JJ, Moya ML, Francis ME, Wang R, Chang SY, Cheng MH, Brey EM. The role of adipose protein derived hydrogels in adipogenesis. Biomaterials. 2008 Sep;29(27):3712-3719. doi: 10.1016/j.biomaterials.2008.05.028. Epub 2008 Jun 24.

  PMID: 18571717 BACKGROUND

• Wu I, Nahas Z, Kimmerling KA, Rosson GD, Elisseeff JH. An injectable adipose matrix for soft-tissue reconstruction. Plast Reconstr Surg. 2012 Jun;129(6):1247-1257. doi: 10.1097/PRS.0b013e31824ec3dc.

  PMID: 22327888 BACKGROUND

Related Links

• Safety Study of Acellular Adipose Tissue for Soft Tissue Reconstruction

MeSH Terms

Conditions

Soft Tissue Injuries; Wounds and Injuries

Study Officials

• Damon Cooney, MD, PhD

  The Department of Plastic and Reconstructive Surgery, Johns Hopkins University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: June 4, 2018
• Study Start: June 21, 2018
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)