Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts
Breast Neoplasms - Skin Abnormalities
Conditions: official terms
Breast Neoplasms - Skin Abnormalities
Conditions: Keywords
breast cancer, loss of elasticity in irradiated breast skin, Other Reconstructive Surgery
Study Type
Study Phase
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Name: Adipose SVF cell Type: Biological
Name: Normal saline Type: Biological
Overall Status
Not yet recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 60 Years
Minimum Age: 40 Years
Gender: Female
Criteria: 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
Seoul National Univ. Bundang Hospital
Bundang-gu, Seongnam-si,Gyeonggi-do, Korea, Republic of
Status: Not yet recruiting
Contact: ChanYoung Heo, Ph.D - 82317877222 - lionheo@snu.ac.kr
Start Date
December 2015
Completion Date
December 2016
Seoul National University Hospital
Seoul National University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page