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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADRC-Enhanced Autologous Fat Transplant | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jules Bordet Institute of Cancer | Brussels | Belgium | ||||
| UniversitĆ degli Studi di Firenze |
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| Florence |
| 50134 |
| Italy |
| Hospital General Universitario Gregorio MaraƱon | Madrid | 28007 | Spain |
| Instituto Valenciano Oncologia | Valencia | 46009 | Spain |
| Glasgow Royal Infirmary | Glasgow | Scotland | G4 0SF | United Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018270 | Carcinoma, Ductal, Breast |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D044584 | Carcinoma, Ductal |
| D000230 | Adenocarcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
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