Status:

WITHDRAWN

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

Lead Sponsor:

Seoul National University Hospital

Conditions:

Breast Neoplasms

Skin Abnormalities

Eligibility:

FEMALE

40-60 years

Phase:

NA

Brief 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 irradiate...

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)ce...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 30 2021

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01801878

Start Date

December 1 2020

End Date

December 30 2021

Last Update

October 23 2020

Active Locations (1)

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1

Seoul National Univ. Bundang Hospital

Seongnam-si, Bundang,Gyeonggi-do, South Korea, 463-707