UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022619 |
|---|---|
| Receipt number | R000026007 |
| Scientific Title | Exploratory study on breast reconstruction method after breast-conserving surgery with autologous stem cell-mixed free fat transplantation. |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2020/12/09 09:19:06 |
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Basic information
Public title
Exploratory study on breast reconstruction method after breast-conserving surgery with autologous stem cell-mixed free fat transplantation.
Acronym
Breast reconstruction by adipose-derived stem cell-mixed free fat transplantation.
Scientific Title
Exploratory study on breast reconstruction method after breast-conserving surgery with autologous stem cell-mixed free fat transplantation.
Scientific Title:Acronym
Breast reconstruction by adipose-derived stem cell-mixed free fat transplantation.
Region
| Japan |
Condition
Condition
Patients with breast deformation following breast-conserving surgery
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the clinical effect and safety of an adipose tissue-regenerative treatment, autologous adipose derived stem cell-mixed free fat transplantation, for breast deformation following surgery for breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative analysis of breast soft tissue: Decreased amounts at postoperative weeks 4 vs. 16
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In the operating room, adipose-derived stem cells were separated from the patient's fat tissue using Icellator Cell Isolation System and its accompanying enzyme, adipase. Fat for transplantation was mixed with the adipose derived stem cells to be injected into the recessed area of the breast.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Female
Key inclusion criteria
1) One or more years after breast-conserving surgery
2) The clinical stage at the time of the above 1) breast-conserving surgery is T1N0M0 early breast cancer (ipsilateral multiple and bilateral breast cancers are ineligible) (refer to the breast cancer stage classification).
Regarding the histology of breast cancer, 1% or more cells are estrogen receptor-positive and HER2 meets one of the following conditions:
Tumor cells in a tissue sample of the primary lesion are (-) or (+) on immunohistological staining (IHC) .
Tumor cells in a tissue sample of the primary lesion are (2+) on IHC and FISH-negative.
3) Female
4) Age from 20 to 79 years old at the time of registration
5) Written informed consent from the patient
Key exclusion criteria
1) Past medical history of ipsilateral multiple or bilateral breast cancers
2) Synchronous double cancer or metachronous cancer diagnosed within 5 years (appropriately treated carcinoma in situ and superficial bladder carcinoma and endoscopically curable malignant tumors are eligible)
3) Past medical history of anticancer drug administration for breast cancer
4) Infection of the breast for which transplantation is planned and the abdominal region from which fat will be collected
5) Local recurrence of breast cancer, distant metastasis, and double cancer
6) Active infection
7) Serious complications (heart, lung, liver, and kidney diseases, hemorrhagic tendency, and uncontrollable diabetes and hypertension)
8) Treatment with oral anticoagulants and antiplatelet agents
9) Pregnant and lactating women and possibly pregnant women
10) Alcohol or drug dependence within the past 6 months
11) Being judged as ineligible by the physician in charge of the study
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Kusumoto |
Organization
Kansai Medical University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
2-5-1, Shinmachi, Hirakata city, 573-1010, Japan
TEL
072-804-0101
kusumoto@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Natsuko Kakudo |
Organization
Kansai Medical University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
2-5-1, Shinmachi, Hirakata city, 573-1010, Japan
TEL
072-804-0101
Homepage URL
kakudon@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 06 | Day |
Last modified on
| 2020 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026007
