UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bone regenerative medicine using allogeneic bone marrow derived mesenchymal stem cells secretome
Title of the study (Brief title)	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
Name of lead principal investigator	Wataru Katagiri
Organization	Nagoya University Hospital
Division name	Oral and Maxillofacial Surgery
Address	65, Tsuruma-Cho, Showa-ku, Nagoya, Japan
TEL	052-744-2348
Email	w-kat@med.nagoya-u.ac.jp

Public contact
Name of contact person	Wataru Katagiri
Organization	Nagoya University Hospital
Division name	Oral and Maxillofacial Surgery
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 02 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000013228