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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN C000000458
Receipt No. R000000559
Scientific Title Cell-assisted lipotransfer (CAL) after breast-conserving therapy
Date of disclosure of the study information 2006/08/01
Last modified on 2010/01/08

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Basic information
Public title Cell-assisted lipotransfer (CAL) after breast-conserving therapy
Acronym Cell-assisted lipotransfer (CAL) after breast-conserving therapy
Scientific Title Cell-assisted lipotransfer (CAL) after breast-conserving therapy
Scientific Title:Acronym Cell-assisted lipotransfer (CAL) after breast-conserving therapy
Region
Japan

Condition
Condition deformity after breast-conserving therapy
Classification by specialty
Breast surgery Plastic surgery Aesthetic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 reformation of the deformity after breast-conserving therapy
soft tissue augmentation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes volume, chest circumference, safety and efficacy
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 Maneuver
Interventions/Control_1 from 1st August, 2006 to 31st July, 2010
injection of adipose tissue and adipose derived (stem) cells
single or multiple surgical procedures
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

Not applicable
Gender Female
Key inclusion criteria healthy person
Key exclusion criteria recurrence of breast cancer
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name KAORU, Okazaki
Organization CELLPORT CLINIC YOKOHAMA
Division name CELLPORT CLINIC YOKOHAMA
Zip code
Address YOKOHAMA EXCELLENT III 2F, 3-35, MINAMINAKADORI, NAKA-KU, YOKOHAMA, KANAGAWA JAPAN
TEL 045-222-3338
Email

Public contact
Name of contact person
1st name
Middle name
Last name KAORU, Okazaki
Organization CELLPORT CLINIC YOKOHAMA
Division name CELLPORT CLINIC YOKOHAMA
Zip code
Address YOKOHAMA EXCELLENT III 2F, 3-35, MINAMINAKADORI, NAKA-KU, YOKOHAMA, KANAGAWA JAPAN
TEL 045-222-3338
Homepage URL http://www.cellport.jp
Email anesthes@biomaster.jp

Sponsor
Institute Biomaster, Inc.
Institute
Department

Funding Source
Organization Biomaster, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor University of Tokyo University
St. Marianna University, School of Medicine
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
2006 Year 08 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 Open public recruiting
Date of protocol fixation
2006 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2006 Year 08 Month 01 Day
Last follow-up date
2010 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2006 Year 07 Month 31 Day
Last modified on
2010 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000559

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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