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

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT02845180
• Lead Sponsor: Musculoskeletal Transplant Foundation

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-03-03
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-27
• Study Start: 2016-11
• Primary Completion: 2018-06-15
• Study Completion: 2018-06-15
• Last Update Submitted: 2018-09-18
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Histopathology evaluation for number of mature adipocytes via haematoxylin and eosin staining.	6 months	Change from baseline to 6 months in abdominal tissue samples using H \& E staining

Secondary Outcome Measures

Name	Time	Method
Safety of allograft adipose matrix (AAM) injections as determined by the incidence of adverse events.	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.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Philadelphia, Pennsylvania, United States