Patients with breast deformation following breast-conserving surgery
Conditions
Interventions
In the operating room, adipose-derived stem cells were separated from the patient'
s fat tissue using Icellator Cell Isolation System and its accompanying enzyme, adipase. Fat for transplantation was mixed with the adipose derived stem cells to be injected into the recessed area of
Sponsors
Kansai Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) One or more years after breast-conserving surgery 2) The clinical stage at the time of the above 1) breast-conserving surgery is T1N0M0 early breast cancer (ipsilateral multiple and bilateral breast cancers are ineligible) (refer to the breast cancer stage classification). Regarding the histology of breast cancer, 1% or more cells are estrogen receptor-positive and HER2 meets one of the following conditions: Tumor cells in a tissue sample of the primary lesion are (-) or (+) on immunohistological staining (IHC) . Tumor cells in a tissue sample of the primary lesion are (2+) on IHC and FISH-negative. 3) Female 4) Age from 20 to 79 years old at the time of registration 5) Written informed consent from the patient
Exclusion criteria
Exclusion criteria: 1) Past medical history of ipsilateral multiple or bilateral breast cancers 2) Synchronous double cancer or metachronous cancer diagnosed within 5 years (appropriately treated carcinoma in situ and superficial bladder carcinoma and endoscopically curable malignant tumors are eligible) 3) Past medical history of anticancer drug administration for breast cancer 4) Infection of the breast for which transplantation is planned and the abdominal region from which fat will be collected 5) Local recurrence of breast cancer, distant metastasis, and double cancer 6) Active infection 7) Serious complications (heart, lung, liver, and kidney diseases, hemorrhagic tendency, and uncontrollable diabetes and hypertension) 8) Treatment with oral anticoagulants and antiplatelet agents 9) Pregnant and lactating women and possibly pregnant women 10) Alcohol or drug dependence within the past 6 months 11) Being judged as ineligible by the physician in charge of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitative analysis of breast soft tissue: Decreased amounts at postoperative weeks 4 vs. 16 | — |
Countries
Japan
Contacts
Public ContactNatsuko Kakudo
Kansai Medical University Department of Plastic and Reconstructive Surgery
Outcome results
None listed