← Back to Search

Tissue-derived Material

AAT for Soft Tissue Reconstruction

Phase 2

Recruiting

Led By Damon Cooney, MD, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Definition of non-childbearing potential for Women: amenorrhea (previous 12 months) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)

Men and women aged 18-65 years with at least one modest (5-30cc) soft tissue defect on the trunk

Must not have

Fever (oral temperature >99º F at time of screening)

Pregnant or Lactating females

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months post-injection

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new material for soft tissue reconstruction called Acellular Adipose Tissue (AAT). AAT is made from adipose tissue (fat), which has unique properties that make it promising for this use. So far, the material has been shown to be safe in animals and humans, and the next phase of the trial will test its efficacy.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include local reactions at the injection site such as redness or swelling, infection risks due to compromised skin integrity post-treatment, and possible immune responses if sensitive to components within the AAT.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman who cannot become pregnant due to menopause or surgery.

Select...

I am between 18 and 65 years old with a small soft tissue defect on my body.

Select...

I am willing to wait up to 6 months to join the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have a fever above 99º F currently.

Select...

I am currently pregnant or breastfeeding.

Select...

I currently have an infection.

Select...

My wound is not healing properly due to poor blood supply.

Select...

My body has reacted to the AAT material.

Select...

I have a surgical wound that is either infected or not healing well.

Select...

I have cancer or am currently being treated for cancer.

Select...

I use insulin to manage my diabetes.

Select...

I cannot follow or understand post-surgery instructions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months post-injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months post-injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post-injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AAT efficacy for soft-tissue reconstruction - Volume Retention

AAT efficacy for soft-tissue reconstruction - blinded assessors

AAT efficacy for soft-tissue reconstruction - patient-reported

Secondary study objectives

Histopathological analysis of explanted implants

Participant Comfort Surveys

Physician Ease of Use Assessments

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acellular Adipose Tissue (AAT)

2016

Completed Phase 1

~10

0 / 12Eligibility criteria met