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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016515
Receipt No. R000019174
Scientific Title A clinical study of bone regeneration using autologous dental pulp stem cells
Date of disclosure of the study information 2015/02/12
Last modified on 2019/03/24

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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
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
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

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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