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

Study Overview
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Brief Summary
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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).

Official Title
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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.

Conditions
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Breast Neoplasms, Carcinoma, Ductal, Breast, Mammaplasty, Mastectomy, Segmental, Lumpectomy, Breast Reconstruction,

Intervention / Treatment
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* Procedure: ADRC-Enhanced Autologous Fat Transplant


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: ADRC-Enhanced Autologous Fat Transplant|Autologous fat harvested from the patient is enhanced with ADRCs derived from a portion of the harvested fat and transplanted into the breast(s) that have a volume deficit post lumpectomy. This is a single arm study with no control. All patients receive cell therapy.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and physician satisfaction with functional and cosmetic results. Improvement in overall breast deformity measured at 12 months compared to baseline. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in breast volume and shape at 6 and 12 Months compared to baseline. Improvement in skin pigmentation abnormalities at 6 and 12 months compared to Baseline. Improvement in overall breast deformity at 6 Months compared to Baseline. |  | 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast, Stem Cell, Adipose Derived Stem Cells, Adipose Derived Regenerative Cells, ADRC, Reconstructive Breast Surgery, Breast Reconstruction, Cancer, Carcinoma, Autologous fat transplantation, Autologous fat, Cosmetic breast deformities, Functional breast deformity, Lumpectomy, Segmental mastectomy, Quadrantectomy, breast conservation therapy