UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024325
Receipt No. R000027902
Scientific Title Efficacy of neovascularization with quality and quantity control cultured peripheral blood stem cell in fat grafting
Date of disclosure of the study information 2016/10/06
Last modified on 2019/04/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy of neovascularization with quality and quantity control cultured peripheral blood stem cell in fat grafting
Acronym Efficacy of neovascularization with quality and quantity control cultured peripheral blood stem cell in fat grafting
Scientific Title Efficacy of neovascularization with quality and quantity control cultured peripheral blood stem cell in fat grafting
Scientific Title:Acronym Efficacy of neovascularization with quality and quantity control cultured peripheral blood stem cell in fat grafting
Region
Japan

Condition
Condition Fat Grafting
Classification by specialty
Plastic surgery Aesthetic surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For this study, we hypothesize that the addition of autologous bone marrow derived mononuclear cells (MNC), enhanced by a serum-free functional culture system called Quality and Quantity Control Culture System (QQc), to freshly harvested adipose tissue improves the vasculogenesis and angiogenesis of the fat graft, and consequently, leads to less fibrosis, less inflammation and reduced resorption.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Fat graft viability
2. Fat graft quality
3. Fat graft vascularization
4. Gene expression
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Blood Collection
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
80 years-old >=
Gender Male and Female
Key inclusion criteria The patients between 20 and 80 of age undergoing a scheduled liposuction at the Department of Plastic and Reconstructive Surgery at the Juntendo University Hospital are recruited for this prospective study. The patients will be well informed by the operator and are asked to sign an informed consent in which is stated that the adipose tissue will be used for research purposes. They do not fall under any of the exclusion criteria.
Key exclusion criteria The patiets have
1. Smoker
2. Age under 19 or over 81
3. Diabetes
4. hematological abnormalities or malignant processes
5. chemotherapy
6. connective tissue diseases
7, lipodystrophy
8. other (the patients whom the principal investigator assessed as the inappropriate subjects)
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Rica Tanaka
Organization Juntendo University School of Medicine
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address Hongo 2-1-1, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Email rtanaka@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rica Tanaka
Organization Juntendo University School of Medicine
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address Hongo 2-1-1, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Homepage URL
Email rtanaka@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2016 Year 10 Month 06 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 Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 23 Day
Date of IRB
2019 Year 03 Month 22 Day
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2022 Year 03 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
2016 Year 10 Month 06 Day
Last modified on
2019 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027902

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.