AAT for Soft Tissue Reconstruction
Trial Summary
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you have conditions like autoimmune connective tissue disease, insulin-dependent diabetes, or are receiving treatment for cancer, you may be excluded from participating.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the idea that AAT for Soft Tissue Reconstruction is an effective treatment?
The available research shows that AAT, or Acellular Adipose Tissue, is effective for soft tissue reconstruction because it provides a supportive environment for new tissue growth. One study found that combining AAT with other materials improved tissue volume and blood vessel formation in rats. Another study highlighted that AAT has a high long-term retention rate, meaning it stays in place well after being used in treatments. These findings suggest that AAT is a promising option for repairing soft tissue.12345
What data supports the effectiveness of the treatment Acellular Adipose Tissue (AAT) for soft tissue reconstruction?
Research shows that acellular adipose matrix (AAM) can help in soft tissue reconstruction by providing a supportive environment for new tissue growth, similar to the body's natural tissue. Studies in animals have shown that combining AAM with other materials can improve tissue growth and blood vessel formation, which are important for healing.12345
What safety data exists for Acellular Adipose Tissue (AAT) in soft tissue reconstruction?
Safety data for Acellular Adipose Tissue (AAT) in soft tissue reconstruction includes findings from pre-clinical and clinical studies. Pre-clinical studies have shown that AAT is biocompatible and supports adipogenesis in both small (murine) and large (porcine) models. In clinical settings, Phase I safety trials have demonstrated that decellularized human adipose tissue scaffolds can be injected into human volunteers without adverse incidents for up to 127 days. Additionally, AAT implants in healthy volunteers were well tolerated, with increasing cellular infiltration and immune populations observed, suggesting ongoing tissue remodeling and potential for long-term tissue replacement.13567
Is Acellular Adipose Tissue (AAT) safe for use in humans?
Is Acellular Adipose Tissue (AAT) a promising treatment for soft tissue reconstruction?
Yes, Acellular Adipose Tissue (AAT) is a promising treatment for soft tissue reconstruction. It is made from fat tissue that has been processed to remove cells, leaving behind a supportive structure that helps new tissue grow. This structure mimics the natural environment of the body, making it easier for new cells to attach and grow. AAT can be used in various forms, like powders or gels, and has shown potential in healing wounds and regenerating tissue in animal studies. It is also being explored for use in other areas like bone and nerve repair.128910
How is the treatment Acellular Adipose Tissue (AAT) unique for soft tissue reconstruction?
Acellular Adipose Tissue (AAT) is unique because it uses decellularized adipose tissue as a scaffold that mimics the natural environment of body tissues, promoting tissue regeneration without causing immune reactions. This treatment provides a supportive structure for new tissue growth and can be modified for various applications, making it a versatile option for soft tissue reconstruction.128910
Research Team
Damon Cooney, MD, PhD
Principal Investigator
The Department of Plastic and Reconstructive Surgery, Johns Hopkins University School of Medicine
Eligibility Criteria
This trial is for men and women aged 18-65 with a soft tissue defect on the trunk, who can consent to study requirements, including blood tests and birth control. Excluded are those allergic to certain antibiotics, have low tissue vascularity, immune response to AAT material, active cancer treatment, pregnancy or lactation, poor general health or nutrition.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive permanent injection of Acellular Adipose Tissue (AAT) to restore soft tissue defects
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of aesthetic appearance and volume retention
Extended Follow-up
Histopathological analysis and additional assessments conducted up to 12 months post-injection
Treatment Details
Interventions
- Acellular Adipose Tissue (AAT)
Acellular Adipose Tissue (AAT) is already approved in United States for the following indications:
- Soft tissue reconstruction
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
U.S. Army Medical Research and Development Command
Collaborator
Armed Forces Institute of Regenerative Medicine
Collaborator