UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061394 |
|---|---|
| Receipt number | R000070243 |
| Scientific Title | Comparative Longitudinal Evaluation of Autologous Dermal Fibroblasts and Adipose-Derived Stem Cells for Facial Skin Quality: An Exploratory Pilot Clinical Study |
| Date of disclosure of the study information | 2026/04/27 |
| Last modified on | 2026/04/27 20:13:38 |
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Basic information
Public title
Comparative Longitudinal Evaluation of Autologous Dermal Fibroblasts and Adipose-Derived Stem Cells for Facial Skin Quality: An Exploratory Pilot Clinical Study
Acronym
Comparative Longitudinal Evaluation of Autologous Dermal Fibroblasts and Adipose-Derived Stem Cells for Facial Skin Quality: An Exploratory Pilot Clinical Study
Scientific Title
Comparative Longitudinal Evaluation of Autologous Dermal Fibroblasts and Adipose-Derived Stem Cells for Facial Skin Quality: An Exploratory Pilot Clinical Study
Scientific Title:Acronym
Comparative Longitudinal Evaluation of Autologous Dermal Fibroblasts and Adipose-Derived Stem Cells for Facial Skin Quality: An Exploratory Pilot Clinical Study
Region
| Japan |
Condition
Condition
Skin aging in healthy adults
Classification by specialty
| Dermatology | Aesthetic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively evaluate and compare longitudinal changes in facial skin quality following autologous dermal fibroblast and adipose-derived stem cell therapy using clinical data.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in skin parameters measured by NeoVoir at baseline,1,3,and 6 months
Key secondary outcomes
Changes in patient satisfaction scores.
Adverse events.
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults who underwent facial rejuvenation treatment
Availability of baseline clinical data
Key exclusion criteria
Severe skin disease
Deemed unsuitable by investigator
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Teranishi |
Organization
Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
Division name
director
Zip code
5300057
Address
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
TEL
06-6147-2581
umeda.office@tcb.or.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Umeda |
Organization
Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
Division name
Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
Zip code
5300057
Address
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
TEL
06-6147-2581
Homepage URL
dr.umeda.masashi@tcb.or.jp
Sponsor or person
Institute
Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
Institute
Department
Personal name
Funding Source
Organization
none
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
TCB Academic Committee and IRB
Address
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
Tel
06-6147-2581
irb@tcb.or.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
| 2026 | Year | 04 | Month | 27 | 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
6
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
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective observational study evaluating longitudinal changes in skin parameters following dermal fibroblast and adipose-derived stem cell therapy. Primary outcomes are objective skin measurements using NeoVoir, and secondary outcomes include patient satisfaction. Missing follow-up data will not be imputed, and analyses will be conducted using available data only.
Management information
Registered date
| 2026 | Year | 04 | Month | 27 | Day |
Last modified on
| 2026 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070243
