UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000456 |
|---|---|
| Receipt number | R000000554 |
| Scientific Title | Cell-assisted lipotransfer (CAL) |
| Date of disclosure of the study information | 2006/07/29 |
| Last modified on | 2010/01/08 16:17:41 |
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Basic information
Public title
Cell-assisted lipotransfer (CAL)
Acronym
Cell-assisted lipotransfer (CAL)
Scientific Title
Cell-assisted lipotransfer (CAL)
Scientific Title:Acronym
Cell-assisted lipotransfer (CAL)
Region
| Japan |
Condition
Condition
1) breast augmentation
2) breast reconstruction
3) buttock lift
4) congenital or acquired soft tissue defect
Classification by specialty
| Plastic surgery | Aesthetic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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, buttock circumeference
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 29th July, 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy person
Key exclusion criteria
recurrence of breast cancer (case: breast reconstruction)
Target sample size
200
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
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
anesthes@biomaster.jp
Sponsor or person
Institute
Biomaster, Inc.
Institute
Department
Personal name
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
Ritz Cosmetic Surgery Clinic Tokyo
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
| 2006 | Year | 07 | Month | 29 | 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 | 29 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 07 | 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 | 28 | Day |
Last modified on
| 2010 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000554
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
