Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts

Study Overview
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Brief Summary
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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
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10 participants who taken conservative mastectomy will be enrolled 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. Duration of study entire duration: approximate 30weeks Follow-up period: 12 weeks Enrollment period: 12 weeks Study design - Randomized, prospective, pilot study

Official Title
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Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts

Conditions
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Breast Neoplasms, Skin Abnormalities

Intervention / Treatment
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* Biological: Adipose SVF cell
* Biological: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adipose SVF cell<br>adipose SVF cell transfer to the half of irradiated breast | Biological: Adipose SVF cell<br>* adipose SVF cell transfer to the half of irradiated breast<br>|
| Active Comparator: Normal saline<br>Normal saline inject to the half of irradiated breast | Biological: Normal saline<br>* Normal saline inject to the half of irradiated breast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, loss of elasticity in irradiated breast skin, Other Reconstructive Surgery