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

Seoul National University

Status: Withdrawn

Conditions: Skin Abnormalities; Breast Neoplasms

Treatments: Biological: Normal saline; Biological: Adipose SVF cell

Study type: Interventional

Funder types: Other

Identifiers

NCT01801878

B-1206-158-005

06-2012-193 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Adipose SVF cell

Experimental group

Description:

adipose SVF cell transfer to the half of irradiated breast

Treatment:

Biological: Adipose SVF cell

Normal saline

Active Comparator group

Description:

Normal saline inject to the half of irradiated breast

Treatment:

Biological: Normal saline