Acellular Adipose Tissue (AAT) for Soft Tissue Reconstruction
Soft Tissue Injuries, Trauma
About this trial
This is an interventional treatment trial for Soft Tissue Injuries focused on measuring adipose-derived extracellular matrix (ECM), acellular adipose tissue (AAT)
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins University School of Medicine
Arms of the Study
Arm 1
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).