Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts
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
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
The change in the breast skin thickness of the pre and post SVF graft from baseline at 12week after procedure
The efficacy is assessed by breast skin thickness measured by radiologist using breast ultrasonography
change in the breast skin thickness from baseline at 12 week
No
Chanyeong Heo, Ph.D
Principal Investigator
Seoul National University Bundang Hospital
Korea: Food and Drug Administration
B-1206-158-005
NCT01801878
May 2013
December 2013
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