UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049141 |
|---|---|
| Receipt number | R000055967 |
| Scientific Title | Research of human adipose tissue regeneration by mixed injection of basic fibroblast growth factor (bFGF) and platelet rich plasma (PRP) ? |
| Date of disclosure of the study information | 2022/10/30 |
| Last modified on | 2024/10/07 11:26:35 |
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Basic information
Public title
Is it true that human adipose tissue regeneration by mixed injection of basic fibroblast growth factor (bFGF) and platelet rich plasma (PRP) ?
Acronym
Research of human adipose tissue regeneration by mixed injection of bFGF and PRP
Scientific Title
Research of human adipose tissue regeneration by mixed injection of basic fibroblast growth factor (bFGF) and platelet rich plasma (PRP) ?
Scientific Title:Acronym
Research of human adipose tissue regeneration by mixed injection of bFGF and PRP
Region
| Japan |
Condition
Condition
Cases of breast reconstruction using a deep inferior epigastric artery perforator flap or a profunda artery perforator flap
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, in the field of cosmetic surgery, a subcutaneous injection of a mixture of autologous Platelet Rich Plasma( PRP) and basic fibroblast growth factor (b-FGF) promotes tissue growth and improves aging change such as wrinkles and sagging It is widely said. However, there have been many reports of the occurrence of induration and swelling including granuloma, etc., and whether it is really a treatment with no safety problems and what kind of effect it actually has on adipose tissue. It is a big problem that it is popular in Japan as a category of self-funded medical treatment without detailed verification.
Therefore, the purpose of this study is to investigate in detail the conditions for the development of granulomas by mixed PRP and bFGF injections, and to conduct analyses including studies on safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reagent is injected at 4 weeks after fat injection, and fat is removed afterimmunologicalimmunological evaluation.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
patients in which breast reconstruction was performed with a deep inferior epigastoric flap or a profunda artery perforater flap during the period from May 13, 2022-October 30,2024
Key exclusion criteria
Cases with incomplete records.When thr subject declines to participate in the research or withdraws the patient's consent.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Mizuno |
Organization
juntendo university
Division name
plastic and reconstructive surgery
Zip code
113-8431
Address
3-1-3 Hongo Bunkyo-ku Tokyo
TEL
03-3813-3111
hmizuno@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Ito |
Organization
juntendo university
Division name
plastic and reconstructive surgery
Zip code
113-8431
Address
3-1-3 Hongo Bunkyo-ku Tokyo
TEL
03-3813-3111
Homepage URL
tomoitou@juntendo.ac.jp
Sponsor or person
Institute
juntendo university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo Bunkyoku Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.ac.jp
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
| 2022 | Year | 10 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing special
Management information
Registered date
| 2022 | Year | 10 | Month | 06 | Day |
Last modified on
| 2024 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055967
