UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024325 |
|---|---|
| Receipt number | 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 | 2021/04/12 12:10:29 |
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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
90
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
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
rtanaka@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
| 2024 | 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
| 2021 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.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 |
