15 Participants Needed

AAT for Soft Tissue Reconstruction

CC
Overseen ByCarisa Cooney, MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

Research shows that Acellular Adipose Tissue (AAT) has been tested in human volunteers and was well tolerated, with no major safety issues reported. In clinical trials, AAT implants were found to be safe, showing good compatibility and no adverse reactions in humans.13567

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

DC

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

Ability to give informed consent
I am a woman who cannot become pregnant due to menopause or surgery.
Willingness to perform follow up visits for 12 months (+/- 30 days)
See 7 more

Exclusion Criteria

Poor nutrition or general medical condition
Inability to speak or read English
Known allergy or sensitivity to Streptomycin or Amphotericin B
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive permanent injection of Acellular Adipose Tissue (AAT) to restore soft tissue defects

1-2 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of aesthetic appearance and volume retention

6 months
Multiple visits for assessments

Extended Follow-up

Histopathological analysis and additional assessments conducted up to 12 months post-injection

up to 12 months

Treatment Details

Interventions

  • Acellular Adipose Tissue (AAT)
Trial OverviewThe trial studies Acellular Adipose Tissue (AAT) for reconstructing soft tissues after injury or trauma. It's a Phase II study that will test different doses of AAT for safety and effectiveness in repairing tissue defects.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Acellular Adipose Tissue (AAT)Experimental Treatment1 Intervention
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).

Acellular Adipose Tissue (AAT) is already approved in United States for the following indications:

🇺🇸
Approved in United States as Acellular Adipose Tissue (AAT) for:
  • Soft tissue reconstruction

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

U.S. Army Medical Research and Development Command

Collaborator

Trials
296
Recruited
249,000+

Armed Forces Institute of Regenerative Medicine

Collaborator

Trials
7
Recruited
220+

Findings from Research

The adipose-derived extracellular matrix collagen scaffold (ACF) enhances the acellular adipose matrix (AAM) by providing a sustained release of adipokines, which are crucial for promoting the growth of mature adipose tissue.
In experiments with nude mice, the combination of ACF and AAM resulted in the formation of highly vascularized and mature adipose tissue, indicating its potential as an effective strategy for soft-tissue reconstruction.
Combined use of autologous sustained-release scaffold of adipokines and acellular adipose matrix to construct highly vascularized, mature, engineered adipose tissue.Xu, M., He, Y., Li, Y., et al.[2023]
Surgically discarded adipose tissue can be decellularized to create a biomimetic microenvironment that supports the growth of adipose-derived stem cells (ASCs), making it a valuable resource for tissue engineering.
The decellularization process results in a 3D bioscaffold that mimics the natural extracellular matrix, which can be used in various formats for applications like soft tissue regeneration and wound healing.
Decellularized Adipose Tissue Scaffolds for Soft Tissue Regeneration and Adipose-Derived Stem/Stromal Cell Delivery.Morissette Martin, P., Shridhar, A., Yu, C., et al.[2019]
The study successfully created a porous extracellular matrix scaffold from human adipose tissue that retains key components like collagen and laminin, which are important for tissue engineering.
The scaffold demonstrated excellent cellular compatibility, as it supported the proliferation, adhesion, and differentiation of human adipose-derived stem cells, making it a promising candidate for adipose tissue engineering.
[Preparation and evaluation of extracellular matrix scaffold of human adipose tissue].Tian, Y., Liu, Y.[2018]

References

Combined use of autologous sustained-release scaffold of adipokines and acellular adipose matrix to construct highly vascularized, mature, engineered adipose tissue. [2023]
Decellularized Adipose Tissue Scaffolds for Soft Tissue Regeneration and Adipose-Derived Stem/Stromal Cell Delivery. [2019]
[Preparation and evaluation of extracellular matrix scaffold of human adipose tissue]. [2018]
Combining Allograft Adipose and Fascia Matrix as an Off-the-Shelf Scaffold for Adipose Tissue Engineering Stimulates Angiogenic Responses and Activates a Proregenerative Macrophage Profile in a Rodent Model. [2023]
Research Progress on the Immunogenicity and Regeneration of Acellular Adipose Matrix: A Mini Review. [2022]
An immunologically active, adipose-derived extracellular matrix biomaterial for soft tissue reconstruction: concept to clinical trial. [2022]
Developing a clinical grade human adipose decellularized biomaterial. [2023]
Preparing Adipogenic Hydrogel with Neo-Mechanical Isolated Adipose-Derived Extracellular Vesicles for Adipose Tissue Engineering. [2023]
Decellularized Adipose Tissue: Biochemical Composition, in vivo Analysis and Potential Clinical Applications. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Application of Decellularized Adipose Matrix as a Bioscaffold in Different Tissue Engineering. [2023]