UMIN-CTR Clinical Trial

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

periodontitis

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Osaka University

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Osaka University Hospital
Medical Center for Translational Research

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪大学歯学部附属病院（大阪府）

Date of disclosure of the study information

2012

Year

04

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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