UMIN-CTR Clinical Trial

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
Email	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
Email	kakudon@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026007