A Clinical Evaluation Of Adipose Derived Regenerative Cells In The Treatment Of Patients With BrEast Deformities Post Segmental Breast ResecTion (Lumpectomy) With Or Without Radiation ThErapy. A Phase IV Post Market Study.
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