Back to resultsPilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts
Primary Purpose
Breast Neoplasms, Skin Abnormalities
Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Adipose SVF cell
Normal saline
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Neoplasms focused on measuring breast cancer, loss of elasticity in irradiated breast skin, Other Reconstructive Surgery
Eligibility Criteria
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
Sites / Locations
- Seoul National Univ. Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Adipose SVF cell
Normal saline
Arm Description
adipose SVF cell transfer to the half of irradiated breast
Normal saline inject to the half of irradiated breast
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01801878
First Posted
February 27, 2013
Last Updated
October 21, 2020
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01801878
Brief Title
Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts
Official Title
Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty in recruiting research subjects
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
Duration of study
entire duration: approximate 30weeks
Follow-up period: 12 weeks
Enrollment period: 12 weeks
Study design - Randomized, prospective, pilot study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Skin Abnormalities
Keywords
breast cancer, loss of elasticity in irradiated breast skin, Other Reconstructive Surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adipose SVF cell
Arm Type
Experimental
Arm Description
adipose SVF cell transfer to the half of irradiated breast
Arm Title
Normal saline
Arm Type
Active Comparator
Arm Description
Normal saline inject to the half of irradiated breast
Intervention Type
Biological
Intervention Name(s)
Adipose SVF cell
Intervention Description
adipose SVF cell transfer to the half of irradiated breast
Intervention Type
Biological
Intervention Name(s)
Normal saline
Intervention Description
Normal saline inject to the half of irradiated breast
Primary Outcome Measure Information:
Title
The change in the breast skin thickness of the pre and post SVF graft from baseline at 12week after procedure
Description
The efficacy is assessed by breast skin thickness measured by radiologist using breast ultrasonography
Time Frame
change in the breast skin thickness from baseline at 12 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chanyeong Heo, Ph.D
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National Univ. Bundang Hospital
City
Seongnam-si
State/Province
Bundang,Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts
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