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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01801878
Other study ID # B-1206-158-005
Secondary ID 06-2012-193
Status Withdrawn
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date December 30, 2021

Study information

Verified date October 2020
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 30, 2021
Est. primary completion date October 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Adipose SVF cell
adipose SVF cell transfer to the half of irradiated breast
Normal saline
Normal saline inject to the half of irradiated breast

Locations

Country Name City State
Korea, Republic of Seoul National Univ. Bundang Hospital Seongnam-si Bundang,Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 change in the breast skin thickness from baseline at 12 week
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