Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts
Conditions
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
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Intervention
Name: Adipose SVF cell Type: Biological
Name: Normal saline Type: Biological
Overall Status
Not yet recruiting
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
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
Location
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
Sponsors
Seoul National University Hospital
Source
Seoul National University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page