UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016515
Receipt number 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 17:00:05

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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 or person

Institute

Aichi Medical University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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