NCT02845180

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
Last Updated

September 19, 2018

Status Verified

July 1, 2016

Enrollment Period

1.6 years

First QC Date

March 3, 2016

Last Update Submit

September 18, 2018

Conditions

Obesity

Keywords

lipectomypanniculectomy

Outcome Measures

Primary Outcomes (1)

  • Histopathology evaluation for number of mature adipocytes via haematoxylin and eosin staining.

    Change from baseline to 6 months in abdominal tissue samples using H \& E staining

    6 months

Secondary Outcomes (1)

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

    6 months

Study Arms (2)

3 Mo. Post AAM Injection

EXPERIMENTAL

Injection. Adipose Allograft Extracellular Matrix (AAM). Panniculectomy post injection, 3 months.

Procedure: Adipose Allograft Extracellular Matrix (AAM) Injection

6 Month Post AAM Injection

EXPERIMENTAL

Injection. Adipose Allograft Extracellular Matrix (AAM). Panniculectomy post injection, 6 months.

Procedure: Adipose Allograft Extracellular Matrix (AAM) Injection

Interventions

Adipose Allograft Extracellular Matrix (AAM) InjectionPROCEDURE

Injection followed by surgery

3 Mo. Post AAM Injection6 Month Post AAM Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Philadelphia, Pennsylvania, 15261, United States

Location

Related Publications (4)

  • Flynn LE. The use of decellularized adipose tissue to provide an inductive microenvironment for the adipogenic differentiation of human adipose-derived stem cells. Biomaterials. 2010 Jun;31(17):4715-24. doi: 10.1016/j.biomaterials.2010.02.046. Epub 2010 Mar 20.

    PMID: 20304481BACKGROUND

  • Brown BN, Freund JM, Han L, Rubin JP, Reing JE, Jeffries EM, Wolf MT, Tottey S, Barnes CA, Ratner BD, Badylak SF. Comparison of three methods for the derivation of a biologic scaffold composed of adipose tissue extracellular matrix. Tissue Eng Part C Methods. 2011 Apr;17(4):411-21. doi: 10.1089/ten.TEC.2010.0342. Epub 2011 Feb 5.

    PMID: 21043998BACKGROUND

  • Wu I, Nahas Z, Kimmerling KA, Rosson GD, Elisseeff JH. An injectable adipose matrix for soft-tissue reconstruction. Plast Reconstr Surg. 2012 Jun;129(6):1247-1257. doi: 10.1097/PRS.0b013e31824ec3dc.

    PMID: 22327888BACKGROUND

  • Omidi E, Fuetterer L, Reza Mousavi S, Armstrong RC, Flynn LE, Samani A. Characterization and assessment of hyperelastic and elastic properties of decellularized human adipose tissues. J Biomech. 2014 Nov 28;47(15):3657-63. doi: 10.1016/j.jbiomech.2014.09.035. Epub 2014 Oct 7.

    PMID: 25446266BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Injections

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2016

First Posted

July 27, 2016

Study Start

November 1, 2016

Primary Completion

June 15, 2018

Study Completion

June 15, 2018

Last Updated

September 19, 2018

Record last verified: 2016-07

Locations

US(1)