UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for isolation of adipose derived stem cells for periodontal regeneration therapy.
Title of the study (Brief title)	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	Masahiro Saito
Organization	Tohoku University Graduate School of Dentistry
Division name	Department of Restorative Dentistry Division of Operative Dentistry
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	Keisuke Handa
Organization	Tohoku University Graduate School of Dentistry
Division name	Department of Restorative Dentistry Division of Operative Dentistry
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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