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

40 Years
60 Years
Not Enrolling
Breast Neoplasms, Skin Abnormalities

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Trial Information

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

2. Duration of study

- entire duration: approximate 30weeks

- Follow-up period: 12 weeks

- Enrollment period: 12 weeks

3. Study design - Randomized, prospective, pilot study

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

The change in the breast skin thickness of the pre and post SVF graft from baseline at 12week after procedure

Outcome Description:

The efficacy is assessed by breast skin thickness measured by radiologist using breast ultrasonography

Outcome Time Frame:

change in the breast skin thickness from baseline at 12 week

Safety Issue:


Principal Investigator

Chanyeong Heo, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Bundang Hospital


Korea: Food and Drug Administration

Study ID:




Start Date:

May 2013

Completion Date:

December 2013

Related Keywords:

  • Breast Neoplasms
  • Skin Abnormalities
  • breast cancer
  • loss of elasticity in irradiated breast skin
  • Other Reconstructive Surgery
  • Congenital Abnormalities
  • Breast Neoplasms
  • Neoplasms
  • Skin Abnormalities