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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011286
Receipt No. R000013222
Scientific Title Safety investigations for the bone regenerative medicine using growth factors secreted from the patients' own stem cells
Date of disclosure of the study information 2013/07/27
Last modified on 2016/08/10

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Basic information
Public title Safety investigations for the bone regenerative medicine using growth factors secreted from the patients' own stem cells
Acronym Bone regeneration using the condition media from stem cells
Scientific Title Safety investigations for the bone regenerative medicine using growth factors secreted from the patients' own stem cells
Scientific Title:Acronym Bone regeneration using the condition media from stem cells
Region
Japan

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

Objectives
Narrative objectives1 Safety investigations of bone regeneration using stem cell derived growth factors
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes No complicatons and side effects will be seen 6 month after application
Key secondary outcomes

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
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 after tooth extraction
Patients who have periodontal pockets (over 4mm) after initial periodontal therapy
Key exclusion criteria Patients who have contraindications for any surgery
Patients who have bone metabolic disease such as osteoporosis, diabetes and neoplasms
Patients who are treating with bisphosphonate or who have a history of treatment by BPs.
Patients who are pregnancy, suspected pregnancy or breast-feeding
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minoru Ueda
Organization Nagoya University Hospital
Division name Oral and Maxillofacial Surgery
Zip code
Address 65, Tsuruma-Cho, Showa-ku, Nagoya, Japan
TEL 052-742348
Email w-kat@med.nagoya-u.ac.jp

Public contact
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,
TEL 052-744-2348
Homepage URL
Email w-kat@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Granis-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

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 27 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2011 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 29 Day
Last follow-up date
2014 Year 09 Month 28 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=R000013222

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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