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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032708
Receipt No. 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

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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
Email 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
Email khanda@dent.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Dentistry
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037295

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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