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

IRB00155003

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.

2018-06-21

2025-02-28

2025-12-31

Recruiting

Early phase I

15

Inclusion Criteria: 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). 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: * 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 * Known allergy or sensitivity to Streptomycin or Amphotericin B * Any other reason the study physicians judge would be a contraindication for receiving AAT injections

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ESTIMATED'}}

2024-02-09