Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy

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 treatment ≤12 months prior to enrollment
• Presence of any other known malignancy
• Body Mass Index (BMI) >30
• Plan to undergo weight reduction surgery or foresee any significant weight changes during the study (defined as changes in BMI >5 compared to baseline
• Presence of contraindications to MRI