UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018680 |
|---|---|
| Receipt number | R000021575 |
| Scientific Title | Clinical study of breast reconstruction by multistep cell-assisted lipotransfer (Step-CAL) method with cultivated autologous adipose-derived stromal stem cells (ASC) after mastectomy for breast cancer |
| Date of disclosure of the study information | 2015/08/17 |
| Last modified on | 2024/10/09 15:19:50 |
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Basic information
Public title
Clinical study of breast reconstruction by multistep cell-assisted lipotransfer (Step-CAL) method with cultivated autologous adipose-derived stromal stem cells (ASC) after mastectomy for breast cancer
Acronym
Clinical study of breast reconstruction by multistep cell-assisted lipotransfer (Step-CAL) method with cultivated autologous adipose-derived stromal stem cells (ASC) after mastectomy for breast cancer
Scientific Title
Clinical study of breast reconstruction by multistep cell-assisted lipotransfer (Step-CAL) method with cultivated autologous adipose-derived stromal stem cells (ASC) after mastectomy for breast cancer
Scientific Title:Acronym
Clinical study of breast reconstruction by multistep cell-assisted lipotransfer (Step-CAL) method with cultivated autologous adipose-derived stromal stem cells (ASC) after mastectomy for breast cancer
Region
| Japan |
Condition
Condition
Breast reconstruction after mastectomy for breast cancer
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the safety of the breast reconstruction by Step-CAL method using cultivated autologous adipose-derived stromal stem cells after mastectomy for breast cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Every adverse event occurred in the period from the first liposuction to the last observation day will be assessed by the relation with the treatment, incidence rate, severity, and seriousness.
Key secondary outcomes
(1)volume (rate of engraftment): change in the period from enrollment to 6 months after the last lipoinjection
(2) projection (rate of restoration): change in the period from the enrollment to 6 months after the last lipoinjection
(3) evaluation of cells: evaluation of cultivation process and cultivated cells
(4) questionnaire to the subjects
(5) rate of completion of the treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
(1) Placement and removal of tissue expander (TE)
For breast reconstruction, TE will be placed in the target breast in the first operation and removed in the fourth operation.
(2) Liposuction
In the first, the second, and the third operations with intervals of 4 to 6 months, fat will be aspirated from abdomen, buttocks, or thighs of patient. The fat will be used for injection into the breast and for preparation of ASC. The ASC prepared from approximately 20 ml of fat will be cultivated and cryopreserved for the next operation.
(3) Lipoinjection
In the second, the third, and the fourth operations, the aspirated fat will be mixed with the cryopreserved ASC and injected into the breast. In each operation, the TE will be taken out from the breast before fat injection and the volume of the TE will be reduced appropriately. After fat injection, the TE will be placed into the breast again.
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
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Woman underwent mastectomy in a breast for breast cancer of 0-II TNM classification
(2) Age 20 years or more, and 60 years or less
(3)Patient signed the consent form of this study
Key exclusion criteria
(1) Patient underwent tissue expander placement in the breast after the mastectomy
(2) Any gross distortion derived from endogenous or exogenous cause is seen in the healthy breast
(3) Patient underwent the mastectomy within a year
(4) Patient has any cancer or history of cancer except the breast cancer within 5 years
(5) Body Mass Index (BMI) less than 18
(6) Patient is or may be infected with hepatitis B, hepatitis C, HIV, HTLV, or parvovirus B19
(7) Patient has severe allergy to any substances including antibiotics or bovine serum components
(8) Patient has any of the following complications: (a) autoimmune disease (b) uncontrollable ischemic heart disease, diabetes mellitus, or mental disorder
(9) Patient is enrolled or has been enrolled into any other clinical study within 6 months
(10) Patient is or may be pregnant
(11) Patient has been judged not to be eligible for the study subject by the attending physician
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Tsuji |
Organization
Cellport Clinic YOKOHAMA
Division name
President
Zip code
2310006
Address
Yokohama Excellent III 2F, 3-35, Minaminakadori, Naka-ku, Yokohama, Japan
TEL
045-222-3338
tsuji@cellport.jp
Public contact
Name of contact person
| 1st name | Hidaka |
| Middle name | |
| Last name | Urano |
Organization
Biomaster, Inc.
Division name
Administration division
Zip code
2310006
Address
Yokohama Excellent III 2F, 3-35, Minaminakadori, Naka-ku, Yokohama, Japan
TEL
045-222-3363
Homepage URL
urano@biomaster.jp
Sponsor or person
Institute
Cellport Clinic YOKOHAMA
Institute
Department
Personal name
Funding Source
Organization
Biomaster, Inc.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Biomaster, Inc.
Address
Yokohama Excellent III 2F, 3-35, Minaminakadori, Naka-ku, Yokohama, Japan
Tel
045-222-3363
urano@biomaster.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
PB3150003
Org. issuing International ID_1
Ministry of Health, Labor and Welfare
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 17 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jjpnprs/43/5/43_245/_pdf/-char/ja
Publication of results
Unpublished
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jjpnprs/43/5/43_245/_pdf/-char/ja
Number of participants that the trial has enrolled
5
Results
For all five patients, no laboratory test abnormalities or adverse events attributed to treatment were observed between treatment initiation and final observation. The amount of fat required for treatment was significantly reduced by culturing ASCs, and the operation time was shortened. The aesthetic results for the reconstructed breasts were generally good, although differences from the contralateral breast remained in some cases.
Results date posted
| 2024 | Year | 10 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This single-arm, open-label, clinical study was performed on five patients after mastectomy for breast cancer.
Participant flow
After tissue expander insertion, the breast was reconstructed by CAL repeated for three sessions using cultured ASCs at 4-6 month intervals. Final observations were made at 6 months after the third CAL procedure. During the treatment course, all adverse events were recorded to evaluate safety, and the reconstructed breast volume was measured by three-dimensional image analysis and compared with the contralateral healthy breast to evaluate the volume recovery rate and cosmetic results.
Adverse events
none
Outcome measures
Every adverse event occurred in the period from the first liposuction to the last observation day will be assessed by the relation with the treatment, incidence rate, severity, and seriousness.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 14 | Day |
Last modified on
| 2024 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021575
