Breast reconstruction after mastectomy for breast cancer
Conditions
Interventions
(1) Placement and removal of tissue expander (TE) For breast reconstruction, TE will be placed in the target breast in the first operation and removed in the fourth operation. (2) Liposuction In
Sponsors
Cellport Clinic YOKOHAMA
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Woman underwent mastectomy in a breast for breast cancer of 0-II TNM classification (2) Age 20 years or more, and 60 years or less (3)Patient signed the consent form of this study
Exclusion criteria
Exclusion criteria: (1) Patient underwent tissue expander placement in the breast after the mastectomy (2) Any gross distortion derived from endogenous or exogenous cause is seen in the healthy breast (3) Patient underwent the mastectomy within a year (4) Patient has any cancer or history of cancer except the breast cancer within 5 years (5) Body Mass Index (BMI) less than 18 (6) Patient is or may be infected with hepatitis B, hepatitis C, HIV, HTLV, or parvovirus B19 (7) Patient has severe allergy to any substances including antibiotics or bovine serum components (8) Patient has any of the following complications: (a) autoimmune disease (b) uncontrollable ischemic heart disease, diabetes mellitus, or mental disorder (9) Patient is enrolled or has been enrolled into any other clinical study within 6 months (10) Patient is or may be pregnant (11) Patient has been judged not to be eligible for the study subject by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Every adverse event occurred in the period from the first liposuction to the last observation day will be assessed by the relation with the treatment, incidence rate, severity, and seriousness. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)volume (rate of engraftment): change in the period from enrollment to 6 months after the last lipoinjection (2) projection (rate of restoration): change in the period from the enrollment to 6 months after the last lipoinjection (3) evaluation of cells: evaluation of cultivation process and cultivated cells (4) questionnaire to the subjects (5) rate of completion of the treatment | — |
Countries
Japan
Contacts
Public ContactHidaka Urano
Biomaster, Inc. Administration division
Outcome results
None listed