UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007698 |
|---|---|
| Receipt number | 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 11:25:54 |
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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
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
ipshinya@dent.osaka-u.ac.jp
Public contact
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
kitamura@dent.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008984
