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

Not Applicable

Withdrawn

• Conditions: Breast Neoplasms; Skin Abnormalities
• Interventions: Biological: Adipose SVF cell; Biological: Normal saline

• Registration Number: NCT01801878
• Lead Sponsor: Seoul National University Hospital

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 irradiated breasts.

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)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 Timeline

• Study First Submitted: 2013-02-27
• Study First Submitted QC: 2013-02-28
• Study First Posted: 2013-03-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-23
• Study Start: 2020-12-01
• Primary Completion: 2021-10-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adipose SVF cell	Adipose SVF cell	adipose SVF cell transfer to the half of irradiated breast
Normal saline	Normal saline	Normal saline inject to the half of irradiated breast

Primary Outcome Measures

Name	Time	Method
The change in the breast skin thickness of the pre and post SVF graft from baseline at 12week after procedure	change in the breast skin thickness from baseline at 12 week	The efficacy is assessed by breast skin thickness measured by radiologist using breast ultrasonography

Trial Locations

Locations (1)

Seoul National Univ. Bundang Hospital; 🇰🇷 Seongnam-si, Bundang,Gyeonggi-do, Korea, Republic of