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

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.

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