In-Vivo Assessment of Adipose Allograft Extracellular Matrix in Abdominoplasty Patients

September 18, 2018 updated by: Musculoskeletal Transplant Foundation
The purpose of this study is to assess local tissue reaction and retention of an adipose allograft extracellular matrix at 3 or 6 months post-injection into the subcutaneous abdominal tissue of healthy volunteers scheduled to undergo elective panniculectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized, two arm, single center study to assess adipose tissue development and retention when an implantable allograft adipose matrix ('AAM') is injected in the abdominal subcutaneous tissue of healthy volunteers undergoing elective standard-of-care panniculectomy. This study will enroll ten (10) subjects. These subjects will be randomized to one of two study arms. Arm 1 will consist of five (5) subjects who will receive injections of AAM to be followed clinically for three (3) months duration, and arm 2 will consist of five (5) subjects who will receive injections of AAM to be followed clinically for six (6) months duration. At the point of completion of each arm, 3 or 6 months, the injected tissue will be surgically removed as part of the panniculectomy procedure. Samples of the AAM injected tissue areas and surrounding tissue will be obtained and processed for histologic evaluation.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 15261
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Scheduled to undergo elective abdominoplasty.
  • Able to provide informed consent.
  • Able to understand and comply with the study design and are willing to return for all of the research required follow-up visits.
  • BMI great than or equal to 23 and less than or equal to 35.
  • Thickness of subcutaneous tissue on abdominal wall is at least 2cm thick.
  • If a female, must test negative on a urine pregnancy test.
  • If a female, must be willing to utilize an acceptable method of birth control (i.e., oral contraceptives, condom with spermicide, etc.) for the duration of the study.

Exclusion Criteria:

  • Thickness of subcutaneous tissue on abdominal wall is less than 2cm thick.
  • Previous liposuction at intended sites of treatment.
  • Actively taking immunosuppressive therapy including systemic steroids (intranasal/inhaled steroids are acceptable).
  • Actively receiving chemotherapy or radiation treatment.
  • Subjects with a life expectancy of less than 9 months, terminal conditions or factors making follow-up difficult (e.g.; no fixed address, telephone, etc.)
  • Subjects with intolerance to additional study-associated drugs/therapies (e.g.; lidocaine, etc.).
  • Subjects with known coagulopathy.
  • Subjects on chronic anticoagulants (e.g. Coumadin, etc.).
  • Subjects who are pregnant, lactating or planning pregnancy during the study period.
  • Subjects with abnormal blood chemistry or any abnormal laboratory finding considered clinically significant in that it would deem the subject inappropriate for surgical procedures, as determined by the Investigator (i.e., CBC with Differential, platelets, comprehensive metabolic panel to include electrolytes, bun/creatinine, liver function test and coagulation tests).
  • Subjects who have, as determined by the investigator, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study (e.g.; Type I and II diabetic patients).
  • Subjects with known alcohol or narcotic drug dependency that is deemed to impact compliance.
  • Subjects with diagnosed autoimmune disorders known to affect wound healing, such as Systemic Lupus Erythematosis (SLE), psoriasis, infection and inflammation (seborrheic dermatitis).
  • Subjects currently enrolled in another investigational study.

Study Population Description: Patients scheduled to undergo elective abdominoplasty Sampling Method: Invitation to volunteer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3 Mo. Post AAM Injection
Injection. Adipose Allograft Extracellular Matrix (AAM). Panniculectomy post injection, 3 months.
Procedure: Adipose Allograft Extracellular Matrix (AAM) Injection
Injection followed by surgery
Experimental: 6 Month Post AAM Injection
Injection. Adipose Allograft Extracellular Matrix (AAM). Panniculectomy post injection, 6 months.
Procedure: Adipose Allograft Extracellular Matrix (AAM) Injection
Injection followed by surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histopathology evaluation for number of mature adipocytes via haematoxylin and eosin staining.
Time Frame: 6 months
Change from baseline to 6 months in abdominal tissue samples using H & E staining
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of allograft adipose matrix (AAM) injections as determined by the incidence of adverse events.
Time Frame: 6 months
Ongoing analysis of adverse events collected for the duration of a subject's participation and ongoing aggregate analysis of all subjects' adverse events. These endpoints will not be tested statistically unless unusual or unexpected results are obtained.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Musculoskeletal Transplant Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

June 15, 2018

Study Completion (Actual)

June 15, 2018

Study Registration Dates

First Submitted

March 3, 2016

First Submitted That Met QC Criteria

July 22, 2016

First Posted (Estimate)

July 27, 2016

Study Record Updates

Last Update Posted (Actual)

September 19, 2018

Last Update Submitted That Met QC Criteria

September 18, 2018

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MTF 16-02-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Decision to be made at study site appointment

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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