Breast Neoplasms, Skin Abnormalities
Conditions
Keywords
breast cancer, loss of elasticity in irradiated breast skin, Other Reconstructive Surgery
Brief summary
The aim of this study is to evaluate the skin quality of using adipose-drived stromal vascular fraction (SVF) cell taken by automatic centrifuge for adipose-drived cell isolation system into irradiated breasts.
Detailed description
10 participants who taken conservative mastectomy will be enrolled 1. Process * adipose tissue is obtained from the subject's thigh or abdomen * adipose-drived stromal vascular fraction(SVF)cell isolation using automatic centrifuge system * adipose-drived stromal vascular fraction(SVF)cell graft into the irradiated breast. 2. Duration of study * entire duration: approximate 30weeks * Follow-up period: 12 weeks * Enrollment period: 12 weeks 3. Study design - Randomized, prospective, pilot study
Interventions
BIOLOGICALAdipose SVF cell
adipose SVF cell transfer to the half of irradiated breast
BIOLOGICALNormal saline
Normal saline inject to the half of irradiated breast
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Female aged between 40 and 60 * Subjects who diagnosed breast ductal carcinoma in situ of surgical staging T1aN0, negative resection margin of below 2mm in histopathologic examination * Subjects who have a relapse-free interval of more than one year after breast-conserving surgery for breast cancer and radiation therapy * Subjects who understand the study contents and sign the informed consent
Exclusion criteria
* Subjects who have radiodermatitis * Subjects who planned breast reconstruction with autogenous tissue (ex.Transverse Rectus Abdominis Muscle flap) * Subjects who have a history of smoking within 3months recently * Subjects who participated in other clinical trial within 30 days recently * Pregnant or lactating subjects * Subjects who have a active infectious disease * Subjects who are not eligible for this study at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in the breast skin thickness of the pre and post SVF graft from baseline at 12week after procedure | change in the breast skin thickness from baseline at 12 week | The efficacy is assessed by breast skin thickness measured by radiologist using breast ultrasonography |
Countries
South Korea
Outcome results
None listed