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| Name | Class |
|---|---|
| Cosmeticsurg.net | OTHER |
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Six female patients (>18 years of age, pre-menopausal) who have had loco-regional (lumpectomy and radiation) therapy for breast carcinoma and have been at least one-year disease free will undergo liposuction, the autologous SVF cell fraction will be isolated and labeled with CS-1000 in the operating room without entering cell culture, which will then be returned to the patient at the site of breast grafting. Patients will receive a pre-screening MRI . Patients will have an MRI scans over a period of 1 month at Johns Hopkins. Follow-up MRIs at 6,12, and 18 months will also be performed. Only at Johns Hopkins with fluorine being done as part of this investigational study. By performing fluorine MRI and quantification of 19F signal, we hypothesize that the engraftment of transplanted cells can be tracked in ways not possible before, using the total fluorine signal as surrogate marker for cell persistence and survival. We expect that a clinically successful outcome (maintenance of breast contour and volume) will be positively correlated with cell survival. The outcome of this study may pave the way for using 19F MRI cell tracking as a new tool for stem cell therapy in a variety of clinical applications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CS-1000 | Experimental | Breast cancer patients with RIF will undergo liposuction, the autologous SVF cell fraction will be isolated and labeled with CS-1000 in the operating room without entering cell culture, which will then be returned to the patient at the site of breast grafting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS-1000 labeled SVF cells | Drug | Patients will undergo autologous transplantation of CS-1000 labelled SVF cells in a sterile environment. |
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| Measure | Description | Time Frame |
|---|---|---|
| 19F MRI signal over time | The engraftment of transplanted cells will be tracked in ways not possible before, using the total fluorine signal as surrogate marker for cell persistence and survival. | within 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of breast contour and volume | CTCAE/CTEP scale examination criteria (retraction, atrophy, breast and arm edema, ulceration, telangiectasia, and induration/fibrosis will be used for assessments. | within 18 months |
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Inclusion Criteria:
Exclusion Criteria:
3a) Metallic implant 3b) Claustrophobic 4) High risk for surgical intervention because of comorbidities 5) Received treatment with an investigational drug within 30 days of screening.
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| Name | Affiliation | Role |
|---|---|---|
| Jeff WM Bulte, PhD | Johns Hopkins University | Principal Investigator |
| Ricardo Rodriguez, MD | Cosmeticsurg.net | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CosmeticSurg | Lutherville-Timonium | Maryland | 21093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26511652 | Derived | Rose LC, Kadayakkara DK, Wang G, Bar-Shir A, Helfer BM, O'Hanlon CF, Kraitchman DL, Rodriguez RL, Bulte JW. Fluorine-19 Labeling of Stromal Vascular Fraction Cells for Clinical Imaging Applications. Stem Cells Transl Med. 2015 Dec;4(12):1472-81. doi: 10.5966/sctm.2015-0113. Epub 2015 Oct 28. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |