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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011290
Receipt No. R000013228
Scientific Title Bone regenerative medicine using allogeneic bone marrow derived mesenchymal stem cells secretome
Date of disclosure of the study information 2013/07/27
Last modified on 2016/08/10

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Basic information
Public title Bone regenerative medicine using allogeneic bone marrow derived mesenchymal stem cells secretome
Acronym Bone regeneration using allogenic secretomes
Scientific Title Bone regenerative medicine using allogeneic bone marrow derived mesenchymal stem cells secretome
Scientific Title:Acronym Bone regeneration using allogenic secretomes
Region
Japan

Condition
Condition Bone defect due to removal of teeth, Periodontitis
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the effects of bone regeneration by the secretome from allogenic stem cells
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes No complications and side effects will be reported throughout the study
Key secondary outcomes Bone regeneration will be seen in X-ray 6 months after application

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 Treatment
Type of intervention
Device,equipment Other
Interventions/Control_1 MSC-CM Group
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
20 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with bone defect due to removal of teeth
Patients with periodontal pockets (over 4mm) after initial periodontal therapy
Key exclusion criteria Patients who have contraindications for any surgery
Patients who have bone metabolic diseases such as osteoporosis, diabetes and neoplasms
Patients who are or were receiving bisphosphonate therapy
Patients who are pregnant, suspected pregnant and brest-feeding.
Patients who have allergie for anesthetic and antibiotics
Patients who have infectious disease
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Wataru Katagiri
Organization Nagoya University Hospital
Division name Oral and Maxillofacial Surgery
Zip code
Address 65, Tsuruma-Cho, Showa-ku, Nagoya, Japan
TEL 052-744-2348
Email w-kat@med.nagoya-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Wataru Katagiri
Organization Nagoya University Hospital
Division name Oral and Maxillofacial Surgery
Zip code
Address 65 Tsuruma-cho, Showa-ku,Nagoya, Japan
TEL 052-744-2348
Homepage URL
Email w-kat@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
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 名古屋大学医学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2013 Year 07 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
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
2013 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 26 Day
Last modified on
2016 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013228

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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