Breast NeoplasmsNCT01801878
Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts
A study testing Adipose SVF cell and Normal saline in people with Breast Neoplasms and Skin Abnormalities, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Breast Neoplasms, Skin Abnormalities
- What is being tested?
- Adipose SVF cell and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2020to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National Univ. Bundang Hospital
Seongnam-si, Bundang,Gyeonggi-do, 463-707
About this study
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.
Read the 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
- Conditions
- Breast Neoplasms, Skin Abnormalities
- Being tested
- Adipose SVF cell, Normal saline
- Keywords
- breast cancer, loss of elasticity in irradiated breast skin, Other Reconstructive Surgery
- Medical subject headings
- Breast Neoplasms, Skin Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose SVF cellBiological
adipose SVF cell transfer to the half of irradiated breast
Normal salineBiological
Normal saline inject to the half of irradiated breast
| Study group | Role | What they receive |
|---|---|---|
| Adipose SVF cell | Experimental | adipose SVF cell transfer to the half of irradiated breast Receives: Biological: Adipose SVF cell |
| Normal saline | Active comparator | Normal saline inject to the half of irradiated breast Receives: Biological: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: change in the breast skin thickness from baseline at 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study start1 Dec 2020 (estimated)
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Why it stopped: Difficulty in recruiting research subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chanyeong Heo, Ph.D, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801878
- Sponsor's protocol ID
- B-1206-158-005
- Other IDs
- 06-2012-193
- Status last verified
- Oct 2020
- First submitted
- 27 Feb 2013
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts
- ClinicalTrials.gov ID
- NCT01801878
- Acronym / sponsor ID
- B-1206-158-005
- Conditions
- Breast Neoplasms, Skin Abnormalities
- Keywords
- breast cancer, loss of elasticity in irradiated breast skin, Other Reconstructive Surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty in recruiting research subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adipose SVF cell | Experimental | Biological: Adipose SVF celladipose SVF cell transfer to the half of irradiated breast |
| Normal saline | Active comparator | Biological: Normal salineNormal saline inject to the half of irradiated breast |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipose SVF celladipose SVF cell transfer to the half of irradiated breast | Biological | Adipose SVF cell |
| Normal salineNormal saline inject to the half of irradiated breast | Biological | Normal saline |
Primary outcome
The change in the breast skin thickness of the pre and post SVF graft from baseline at 12week after procedure
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chanyeong Heo, Ph.D principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adipose SVF cell and Normal saline in people with Breast Neoplasms and Skin Abnormalities, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the breast skin thickness of the pre and post SVF graft from baseline at 12week after procedure (time frame: change in the breast skin thickness from baseline at 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.