UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032708 |
|---|---|
| Receipt number | R000037295 |
| Scientific Title | Study for isolation of adipose derived stem cells for periodontal regeneration therapy. |
| Date of disclosure of the study information | 2018/05/31 |
| Last modified on | 2018/05/24 17:43:37 |
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Basic information
Public title
Study for isolation of adipose derived stem cells for periodontal regeneration therapy.
Acronym
isolation of adipose derived stem cells.
Scientific Title
Study for isolation of adipose derived stem cells for periodontal regeneration therapy.
Scientific Title:Acronym
isolation of adipose derived stem cells.
Region
| Japan |
Condition
Condition
periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Treatment of periodontal disease
Basic objectives2
Others
Basic objectives -Others
Confirmation of isolation of adipose derived stem cells
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Isolation of adipose derived stem cells in cell processing center of Tohoku university hospital and safety test (infection test), purity test(FACS analysis)
Key secondary outcomes
Differentiation ability of adipose derived stem cells into osteoblast.
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
Educational,Counseling,Training
Type of intervention
| Medicine |
Interventions/Control_1
Isolation of subcutaneous fat
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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Disease name: Tohoku University hospital 5F Foundation for dental outpatients diagnosed as periodontal disease and able to agree with the research plan
(2) stage, stage: mild periodontal disease with gingivitis
(3) Performance Status Grade 0 or 1: (Health condition that normal wound healing and fat collection can be expected)
(4) Age 30 years old and over, under 50 years (at registration)
(5) Gender does not matter
Key exclusion criteria
(Exclusion to affect effectiveness evaluation)
(1) Study subjects who have complicated diabetes, autoimmune disease, cardiovascular disease, etc. and can not expect wound healing
(2) Research subjects who are too thin to take out fat
(Exclusion for affecting safety evaluation)
(3) Research subjects who have allergy to metals
(4) Local anesthesia (xylocaine) Research subjects with allergies
(5) Women who are pregnant, have the possibility of pregnancy, are within 28 days of birth, are lactating
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Saito |
Organization
Tohoku University Graduate School of Dentistry
Division name
Department of Restorative Dentistry Division of Operative Dentistry
Zip code
Address
4-1 Seiryo-machi, Aoba-ku,Sendai, Japan,980-8575
TEL
022-717-8340
mssaito@dent.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Handa |
Organization
Tohoku University Graduate School of Dentistry
Division name
Department of Restorative Dentistry Division of Operative Dentistry
Zip code
Address
4-1 Seiryo-machi, Aoba-ku,Sendai, Japan,980-8575
TEL
022-717-8337
Homepage URL
khanda@dent.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Dentistry
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
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
| 2018 | Year | 05 | Month | 31 | 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
| 2018 | Year | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 24 | Day |
Last modified on
| 2018 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037295
