Grafting of Autologous Adipose Stromal Cell Trial

Inclusion Criteria

• •Patients must consent in writing to participate in the study by signing and dating an informed consent document indicating that the patient has been informed of all pertinent aspects of the study prior to completing any of the screening procedures.
• •Female of any race, age 21-65.
• •Patients must desire a small breast augmentation with a ½-1 cup size increase in their breast volume. (If they wish to have a larger breast size increase, then they must understand a secondary procedure may be required to achieve that size increase).
• •Patients must have a normal physical exam with no breast masses, no nipple discharge, no fibrocystic disease, no axillary adenopathy and/or history of abnormal bleeding.
• •Patients must not be pregnant or lactating when enrolled in the study and must agree to have a pregnancy test (urine or blood) prior to the surgical procedure. - The patient should also not be trying to get pregnant during the course of the study.
• •Patients must have a stable weight and not be fluctuating in their weight (otherwise this will distort volumetric measurements of breast size post operatively, making it impossible to determine true augmentation volume from SVF-enriched AFG).
• •Patients must also consent to be photographed before and after the procedure and at the end of the study.
• •All patients in the level I (randomized) and level II (nonrandomized) part of the study must also consent to undergo ultrasound imaging of the breast prior to the procedure and after the procedure to evaluate and treat any oil-filled cysts that may arise due to the procedure.
• •All patients in the level I (randomized) and level II (nonrandomized) part of the study must also consent to allow their results to be included in any scientific research, scientific publication, or presentations at scientific meetings.
• •All patients in the level I and level II part of the study must also consent to allow their photos to be used for publication in scientific journals, internet website, and patient educational material such as brochures, before and after photos, and patient education videos.
• •All patients in the study must also agree to have mammography done when indicated after the procedure.
• •All patients in the study must agree to have a biopsy of any suspicious abnormality seen on mammography, ultrasound, or MRI during the study.
• •Patients must not be anemic at the time of the procedure (Hg \< 10). If they are anemic at the time of enrollment, they can still be included in the study if the anemia is corrected pre-operatively with iron supplementation. This must be continued during the study to avoid any adverse reporting that may not be related to the procedure (i.e. anemia not caused by SVF-enriched fat grafting)
• •Patients must have no history of abnormal bleeding during surgery, bruising and no personal/family history of coagulopathy.
• •Patients must be off aspirin and other NSAIDs for two weeks prior to the procedure and have a normal blood coagulation panel within two weeks of surgery: Pts \> 150K, PT(INR) \< 1.3, APTT \<1.3×control.
• •Patients must have normal renal function (demonstrated by a Creatinine ≤ 1.5 mg/dl,) and no urinary tract infection (less than 5 WBCs on UA and leukocyte esterase negative on U/A Dipstick). If a UTI is present, the patient may still enroll if this is treated pre-operatively
• •If a multigenerational family history of breast cancer or ovarian cancer is present, a surgical or medical oncologist must evaluate the patient to obtain pre-operative clearance and to provide reassurance that they do not need BRCA testing.
• •Patients with prior radiation to the chest wall (for Hodgkin's disease) may not be included in the study.