Clinical study of breast reconstruction by multistep cell-assisted lipotransfer (Step-CAL) method with cultivated autologous adipose-derived stromal stem cells (ASC) after mastectomy for breast cancer
- Conditions
- Breast reconstruction after mastectomy for breast cancer
- Registration Number
- JPRN-UMIN000018680
- Lead Sponsor
- Cellport Clinic YOKOHAMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 5
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method (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