UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002454 |
|---|---|
| Receipt number | R000003007 |
| Scientific Title | Transplantation of adipose progenitor cell-enriched adipose tissue for soft tissue enhancement and reconstruction |
| Date of disclosure of the study information | 2009/09/10 |
| Last modified on | 2009/09/06 09:27:42 |
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Basic information
Public title
Transplantation of adipose progenitor cell-enriched adipose tissue for soft tissue enhancement and reconstruction
Acronym
Transplantation of adipose progenitor cell-enriched adipose tissue
Scientific Title
Transplantation of adipose progenitor cell-enriched adipose tissue for soft tissue enhancement and reconstruction
Scientific Title:Acronym
Transplantation of adipose progenitor cell-enriched adipose tissue
Region
| Japan | Asia(except Japan) | North America |
Condition
Condition
Situations needing soft tissue augmentation or reconstruction
Classification by specialty
| Surgery in general | Breast surgery | Dermatology |
| Orthopedics | Plastic surgery | Aesthetic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Soft tissue enhancement or reconstruction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Tissue volume, external contour of the tissue
Key secondary outcomes
CT, MRI, Video
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 10 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Having enough fat tissue for the treatment
Key exclusion criteria
Not healthy enough
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshitsugu Hirohi, Kotaro Yoshimura |
Organization
Ritz Cosmetic Surgery Clinic
Division name
Surgery
Zip code
Address
Meguro Toho Building 8F, 3-1-7 Kamiosaki, Shinagawa-ku, Tokyo 141-0021, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Ritz Cosmetic Surgery Clinic
Division name
Surgery
Zip code
Address
Meguro Toho Building 8F, 3-1-7 Kamiosaki, Shinagawa-ku, Tokyo 141-0021, Japan
TEL
Homepage URL
Sponsor or person
Institute
Ritz Cosmetic Surgery Clinic
Institute
Department
Personal name
Funding Source
Organization
Ritz Cosmetic Surgery Clinic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tissue Genesis, Inc. (USA)
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
| 2009 | Year | 09 | Month | 10 | 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
| 2009 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To be reported
Management information
Registered date
| 2009 | Year | 09 | Month | 06 | Day |
Last modified on
| 2009 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003007
