Acellular Adipose Tissue (AAT) for Soft Tissue Reconstruction

Launched by JOHNS HOPKINS UNIVERSITY · May 21, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Acellular Adipose Tissue (AAT) for repairing soft tissue injuries, which can occur from trauma or other causes. AAT is a special material made from fat that has been processed to keep its beneficial properties. Researchers at Johns Hopkins University believe that AAT might be a safer and more effective option compared to existing treatments, and they want to learn more about how well it works in humans.

To participate in this trial, individuals must be between 18 and 65 years old and have a moderate soft tissue defect on their trunk that requires repair. Participants should be willing to wait up to six months to join the study and must agree to follow certain health guidelines, including attending follow-up visits for a year. Throughout the trial, participants will receive AAT injections and will be monitored for safety and effectiveness. It’s important to note that people with certain health conditions, such as autoimmune diseases or infections, may not be eligible to participate. This study is currently recruiting volunteers, and those interested should reach out for more information.

Gender

ALL

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