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ObesityNCT02845180

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

A study testing Adipose Allograft Extracellular Matrix (AAM) Injection in people with Obesity, run by Musculoskeletal Transplant Foundation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Adipose Allograft Extracellular Matrix (AAM) Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Nov 2016to 15 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.).
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pittsburgh

    Philadelphia, Pennsylvania, 15261

Other trials in United States

About this study

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.

Read the 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.

Conditions
Obesity
Being tested
Adipose Allograft Extracellular Matrix (AAM) Injection
Keywords
lipectomy, panniculectomy
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adipose Allograft Extracellular Matrix (AAM) InjectionProcedure or surgery

    Injection followed by surgery

Study groups in NCT02845180
Study groupRoleWhat they receive
3 Mo. Post AAM InjectionExperimentalInjection. Adipose Allograft Extracellular Matrix (AAM). Panniculectomy post injection, 3 months.
Receives: Procedure: Adipose Allograft Extracellular Matrix (AAM) Injection
6 Month Post AAM InjectionExperimentalInjection. Adipose Allograft Extracellular Matrix (AAM). Panniculectomy post injection, 6 months.
Receives: Procedure: Adipose Allograft Extracellular Matrix (AAM) Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (1)

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

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2016 (estimated)
  2. Study startNov 2016
  3. Primary completion15 Jun 2018
  4. Study completion15 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02845180
Sponsor's protocol ID
MTF 16-02-02
Status last verified
Jul 2016
First submitted
3 Mar 2016
Last updated
19 Sep 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided: Decision to be made at study site appointment

Publications

  • 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.

    PubMed 20304481

  • 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.

    PubMed 21043998

  • 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.

    PubMed 22327888

  • 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.

    PubMed 25446266

Questions about this trial

What is this clinical trial studying?

A study testing Adipose Allograft Extracellular Matrix (AAM) Injection in people with Obesity, run by Musculoskeletal Transplant Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Histopathology evaluation for number of mature adipocytes via haematoxylin and eosin staining. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02845180, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.

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