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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months post-injection

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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

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

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Histopathological analysis of explanted implants

Participant Comfort Surveys

Physician Ease of Use Assessments

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,263 Previous Clinical Trials

14,823,150 Total Patients Enrolled

U.S. Army Medical Research and Development CommandFED

286 Previous Clinical Trials

245,744 Total Patients Enrolled

Armed Forces Institute of Regenerative MedicineFED

3 Previous Clinical Trials

77 Total Patients Enrolled

Media Library

Acellular Adipose Tissue (AAT) (Tissue-derived Material) Clinical Trial Eligibility Overview. Trial Name: NCT03544632 — Phase 2

Soft Tissue Injury Research Study Groups: Acellular Adipose Tissue (AAT)

Soft Tissue Injury Clinical Trial 2023: Acellular Adipose Tissue (AAT) Highlights & Side Effects. Trial Name: NCT03544632 — Phase 2

Acellular Adipose Tissue (AAT) (Tissue-derived Material) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03544632 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for participants to join this clinical trial currently?

"Reports on clinicaltrials.gov declare that this medical trial, which first opened its doors to patients in June of 2018 and was modified most recently on September 6th 2022, is not presently accepting new candidates. Conversely, 64 other trials are actively recruiting participants at the present time."

Answered by AI

What criteria must be met to qualify for this research endeavor?

"This clinical trial is open to a maximum of 15 participants between the ages 18 and 65 who have recently sustained soft tissue injuries. In addition to these criteria, applicants must demonstrate their consent for photography used in research purposes, agree to abide by all study instructions, confirm non-childbearing potential (for women only), possess at least one moderate injury on the trunk region that requires treatment within 6 months, and be willing to follow up with researchers over an approximate 12 month period (+/- 30 days)."

Answered by AI

Does this trial accept participants under the age of fifty?

"As specified in the trial's inclusion criteria, only those individuals between 18 and 65 years of age are eligible to participate."

Answered by AI

Is Acellular Adipose Tissue (AAT) a secure option for individuals?

"With Acellular Adipose Tissue (AAT) being in the second stage of clinical trials, there is only anecdotal evidence backing its safety. Accordingly, our team at Power has scored it a 2 on the risk scale."

Answered by AI

Recent research and studies

Aesthetic Surgery JournalJournal

The Science of Autologous Fat Grafting: Views on Current and Future Approaches to Neoadipogenesis

BUCKY, L, and I PERCEC. 2008. “The Science of Autologous Fat Grafting: Views on Current and Future Approaches to Neoadipogenesis”. Aesthetic Surgery Journal. Oxford University Press (OUP). doi:10.1016/j.asj.2008.02.004.

Journal of Craniofacial SurgeryJournal

Craniofacial Autologous Fat Transfer

Wan, Derrick C., Alan T. Lim, and Michael T. Longaker. 2009. “Craniofacial Autologous Fat Transfer”. Journal of Craniofacial Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/scs.0b013e31819921d3.

New England Journal of MedicineJournal

Breast Reconstruction After Surgery for Breast Cancer

Cordeiro, Peter G.. 2008. “Breast Reconstruction After Surgery for Breast Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmct0802899.

Annals of Surgical OncologyJournal