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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002454
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Ritz Cosmetic Surgery Clinic
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003007

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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