UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety investigations for the bone regenerative medicine using growth factors secreted from the patients' own stem cells
Title of the study (Brief title)	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	Minoru Ueda
Organization	Nagoya University Hospital
Division name	Oral and Maxillofacial Surgery
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	Wataru Katagiri
Organization	Nagoya University Hospital
Division name	Oral and Maxillofacial Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
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=R000013222