Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts
NCT ID: NCT01801878
Last Updated: 2020-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2020-12-01
2021-12-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Adipose SVF cell
adipose SVF cell transfer to the half of irradiated breast
Adipose SVF cell
adipose SVF cell transfer to the half of irradiated breast
Normal saline
Normal saline inject to the half of irradiated breast
Normal saline
Normal saline inject to the half of irradiated breast
Interventions
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Adipose SVF cell
adipose SVF cell transfer to the half of irradiated breast
Normal saline
Normal saline inject to the half of irradiated breast
Eligibility Criteria
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Inclusion Criteria
* 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 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
40 Years
60 Years
FEMALE
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Chanyeong Heo, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National Univ. Bundang Hospital
Seongnam-si, Bundang,Gyeonggi-do, South Korea
Countries
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Other Identifiers
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06-2012-193
Identifier Type: OTHER
Identifier Source: secondary_id
B-1206-158-005
Identifier Type: -
Identifier Source: org_study_id
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