A post-marketing study evaluating the transplantation of autologous fat augmented with Adipose Derived Regenerative Cells (ADRCs), in patients with functional and cosmetic breast deformities post segmental mastectomy or quadrantectomy (lumpectomy).
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion Criteria:
* Females with a history of T2N0M0 breast carcinoma (tumor ≤3 cm in largest dimension)
* Surgical or endoscopic segmental mastectomy or quadrantectomy (lumpectomy)
* Clean surgical margins
* No prosthesis in breast(s) to undergo treatment
* Ability to undergo lipoaspiration
* Last treatment for breast cancer ≥ 12 months prior to enrollment with absence of recurrence (patients on anti-estrogen adjuvant therapy are NOT excluded)
* No evidence of recurrence of cancer based on mammogram or breast exam prior to enrollment
* Objective signs of mild breast damage post Breast Conservation Therapy
* Type I Cosmetic Sequelae Classification
* A minimum of 1 cm of soft tissue (e.g. breast or fat) is available between the skin and chest wall at the recipient site
* A minimum of two-thirds of the breast is remaining post Breast Conservation Therapy
* No continuous adhesion of skin to bone \>3 cm in diameter
* The volume and shape of the defect(s) must be conducive to correction during a single treatment session (maximum defect volume ≤150 mL in breast(s) to undergo treatment)
Exclusion Criteria:
* History of autoimmune disorder (e.g., Systemic Lupus Erythematosus \[SLE\])
* History of connective, metabolic or atrophic skin disease
* History of keloid scarring
* Chronic use (\>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days prior to enrollment
* Life expectancy ≤ 2 years
* Recurrence or active malignancy requiring radiation or surgical…
What they're measuring
1
Patient and physician satisfaction with functional and cosmetic results. Improvement in overall breast deformity measured at 12 months compared to baseline.