UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000007698
Receipt No. R000008984
Scientific Title An exploratory open trial to examine the safety of transplantation of autologous adipose tissue-derived stem cells for periodontal regeneration.
Date of disclosure of the study information 2012/04/09
Last modified on 2019/04/15 (Ver. 17)

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Basic information
Public title An exploratory open trial to examine the safety of transplantation of autologous adipose tissue-derived stem cells for periodontal regeneration.
Acronym An exploratory open trial of transplantation of adipose tissue-derived stem cells for periodontal regeneration.
Scientific Title An exploratory open trial to examine the safety of transplantation of autologous adipose tissue-derived stem cells for periodontal regeneration.
Scientific Title:Acronym An exploratory open trial of transplantation of adipose tissue-derived stem cells for periodontal regeneration.
Region
Japan

Condition
Condition periodontitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this clinical trial is to examine the safety and efficacy of transplantation of autologous adipose tissue-derived stem cells for periodontal regeneration.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The occurrence, severity, frequency and period of adverse events
Key secondary outcomes Increase (%) in alveolar bone height
Clinical attachment level (CAL)
Probing pocket depth (PD)
Bleeding on probing (BOP)
Gingival index (GI)
Tooth mobility

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
Medicine Device,equipment Maneuver
Interventions/Control_1 Aspiration of abdominal adipose tissue
Transplantation of adipose tissue-derived stem cells to the experimental site during periodontal surgery
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 (1) Persons who have at least one periodontal pocket more than 7 mm at baseline examination.
(2) Persons who have at least one intra-bony defect (4mm and more depth and 2mm and more width) at interproximal sites of the experimental tooth diagnosed by x-ray examination.
(3) Persons who had received initial preparation at the time of screening for subjects.
(4) Persons whose grade of mobility of experimental teeth is 0, 1 or 2 and whose width of keratinized gingiva is diagnosed to be appropriate for flap surgery.
(5) Persons whose oral hygiene is established and who are judged to hold good compliance for oral hygiene methods instructed by the investigators after the transplantation of adipose tissue derived stem cells.
(6) Persons who are older than 20 years old when obtained informed consents are obtained
(7) Persons whose informed consents to join this study are obtained by the written document
Key exclusion criteria (1) Persons whose clinical attachment level of experimental teeth cannot be measured.
(2) Persons who have or have had malignant tumor.
(3) Persons who are suspected to have malignant tumor or precancerous lesions at the oral cavity inspection before the registration.
(4) Persons who have administered bisphosphonates, or are to administer the drug after the registration.
(5) Persons who need to undergo the treatments, such as surgical treatment, restorative treatment or root canal treatment, which affect the experimental sites within 36 weeks after the transplantation of adipose tissue-derived stem cells.
(6) Persons who are either pregnant, breast-feeding or possibly pregnant by the pregnancy test before the registration, or who hope to become pregnant within 36 weeks after the transplantation of adipose tissue-derived stem cells.
(7) Persons who suffer from disorders of kidney, liver or blood.
(8) Persons whose hemoglobinA1c is more than 6.5% in the blood test before the entry
(9) Persons who suffer from active infectious diseases.
(10) Persons who have the history of dependence on alcohol or drugs within 6 months before the registrarion.
(11) Persons who suffer from mental or consciousness disorders.
(12) Persons who have the positive reaction to the tests for hepatitis C virus antibody, hepatitis B virus antigen, human T-lymphotropic virus-1 antibody or human immunodeficiency virus antibody.
(13) Persons who are judged not eligible for the subjects of this study by the principal investigator.
Target sample size 12

Research contact person
Last name of lead principal investigator
1st name Shinya
Middle name
Last name MURAKAMI
Organization Osaka University Graduate School of Dentistry
Division name Department of Periodontology, Division of Oral Biology and Disease Control
Zip code 565-0871
Address 1-8 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-2930
Email ipshinya@dent.osaka-u.ac.jp

Public contact
1st name of contact person
1st name Masahiro
Middle name
Last name KITAMURA
Organization Osaka University Graduate School of Dentistry
Division name Department of Periodontology, Division of Oral Biology and Disease Control
Zip code 565-0871
Address 1-8 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-2375
Homepage URL
Email kitamura@dent.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka University Hospital
Medical Center for Translational Research
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka University Graduate School of Dentistry / Faculty of Dentistry and Dentistry Hospital Ethics Review Committee
Address 1-8 Yamadaoka, Suita, Osaka, Japan
Tel 06-6879-2831
Email si-soumu-syomu@office.osaka-u.ac.jp

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 大阪大学歯学部附属病院（大阪府）

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 09 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 
The autologous adipose tissue-derived stem cells(ADSC) were transplanted of  into 12 patients, and the safety and effectiveness of periodontal regeneration by ADSC transplantation are currently being examined.
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
2012 Year 09 Month 07 Day
Date of IRB
2012 Year 09 Month 07 Day
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 09 Day
Last modified on
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008984