UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study of bone regeneration using autologous dental pulp stem cells
Acronym	A clinical bone regeneration study with dental pulp stem cells
Scientific Title	A clinical study of bone regeneration using autologous dental pulp stem cells
Scientific Title:Acronym	A clinical bone regeneration study with dental pulp stem cells
Region	Japan

Condition
Condition	Atrophy of alveolar bone
Classification by specialty	Oral surgery Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the safety and efficacy of bone regeneration by transplantation of autologous dental pulp stem cells.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety
Key secondary outcomes	Efficacy of bone regeneration

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	Maneuver
Interventions/Control_1	Transplantation of dental pulp stem cells
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Patients who are capable of making an independent decision to comply with trial requirements and whose informed consents are obtained by oral and written document. (2)Male and female (3)Age >=20-years-old and <=70-years-old (4)Patients who have unnecessary and/or discarded teeth such as wisdom tooth, expendientry extracted tooth for orthodontic treatment, supernumerary tooth or displaced tooth without occlusion to supply pulp tissue. (5)Patients who wish to have dental implant treatment rather than conventional removable prostheses or conserve teeth. (6)Patients who require bone transplantation for dental implant because of severe alveolar ridge atrophy. (The width of alveolar bone at the installation sites is <= 5 mm. In the maxilla, the distance between the alveolar ridge and the sinus floors is <= 5 mm. On the other hand, in the mandible the distance between the ridge and mandibular canal is<= 5 mm.) Finally it is decided by CT evaluation. (7)Patients that oral hygiene is well established. (8)Patients who are able to visit their hospitals in accordance with the trial schedule.
Key exclusion criteria	(1)Patients who have a difficulty in collecting blood. (hemoglobin content < 11g/dl, blood platelet count <=100,000/mm3) (2)Patients who suffer from infectious diseases (positive for HBs antigen, HBc antibody, HCV antibody, HIV antibody, HTLV-1 antibody, and syphilis serology). (3)Patients with coexisting disorder of the blood, circulatory system, kidney, and/or liver. (4)Patients taking anticoagulants or antiplatelet agents. (5)Patients with coexisting diabetes. (6)Patients with coexisting osteoporosis. (7)Patients who have mental or consciousness disorder, the history of dependence on alcohol or drugs. (8)Patients who are either pregnant, possibly pregnant, or who hope to become pregnant during the period of this trial. (9)Patients who have a previous history of allergy to any antimicrobial agent or local anesthesia. Others who the investigators determined as unsuitable for the trial.
Target sample size	10

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Yoichi Yamada
Organization	Aichi Medical University School of Medicine
Division name	Department of Oral and Maxillofacial Surgery
Zip code
Address	1-1 Yazakokarimata, Nagakute, Aichi 480-1195 Japan
TEL	0561-62-3311
Email	yyamada@aichi-med-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Yoichi Yamada
Organization	Aichi Medical University School of Medicine
Division name	Department of Oral and Maxillofacial Surgery
Zip code
Address	1-1 Yazakokarimata, Nagakute, Aichi 480-1195 Japan
TEL	0561-62-3311
Homepage URL
Email	yyamada@aichi-med-u.ac.jp

Sponsor
Institute	Aichi Medical University School of Medicine
Institute
Department

Funding Source
Organization	Aichi Medical University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Cell Therapy Center of Biochemistry, Aichi Medical University School of Medicine
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	愛知医科大学病院（愛知県）Aichi Medical University Hospital(Aichi)

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 12 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	Completed
Date of protocol fixation	2015 Year 02 Month 04 Day
Date of IRB	2015 Year 02 Month 04 Day
Anticipated trial start date	2015 Year 02 Month 20 Day
Last follow-up date	2018 Year 11 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 02 Month 12 Day
Last modified on	2019 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019174