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

Seoul National University Hospital

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Conditions

Breast Neoplasms Skin Abnormalities

Interventions

Adipose SVF cellBIOLOGICAL

adipose SVF cell transfer to the half of irradiated breast

Normal salineBIOLOGICAL

Normal saline inject to the half of irradiated breast

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National Univ. Bundang Hospital

Seongnam-si, Bundang,Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

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

Time frame: change in the breast skin thickness from baseline at 12 week

Data from ClinicalTrials.gov

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