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
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
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
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
