UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034310 |
|---|---|
| Receipt number | R000039083 |
| Scientific Title | A phase I/IIa safety and efficacy study of allogeneic periodontal ligament-derived mesenchymal stromal cell sheet product (TWP-0001) in patients with periodontitis, consisting of 1 wall intrabony defect, Class III furcation defect, or horizontal defect, with probing depths of 4 - 9 mm after the initial therapy |
| Date of disclosure of the study information | 2018/09/28 |
| Last modified on | 2019/10/07 14:39:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A phase I/IIa safety and efficacy study of allogeneic periodontal ligament-derived mesenchymal stromal cell sheet product (TWP-0001) in patients with periodontitis, consisting of 1 wall intrabony defect, Class III furcation defect, or horizontal defect, with probing depths of 4 - 9 mm after the initial therapy
Acronym
Periodontal regeneration by allogeneic periodontal ligament-derived mesenchymal stromal cell sheets
Scientific Title
A phase I/IIa safety and efficacy study of allogeneic periodontal ligament-derived mesenchymal stromal cell sheet product (TWP-0001) in patients with periodontitis, consisting of 1 wall intrabony defect, Class III furcation defect, or horizontal defect, with probing depths of 4 - 9 mm after the initial therapy
Scientific Title:Acronym
Periodontal regeneration by allogeneic periodontal ligament-derived mesenchymal stromal cell sheets
Region
| Japan |
Condition
Condition
Periodontitis, consisting of 1 wall intrabony defect, Class III furcation defect, or horizontal defect, with probing depths of 4 - 9 mm after the initial therapy
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of the safety and efficacy of allogeneic periodontal ligament-derived mesenchymal stromal cell sheet product (TWP-0001) in patients with severe periodontitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety
1) Adverse event
2) Pain scoring by interview and observation
3) Blood tests and urinary tests
Key secondary outcomes
Efficacy
1) Linear bone gain at 26 and 36 weeks after the transplantation.
2) Gain of clinical attachment level
3) Changes of periodontal examinations
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Allogeneic periodontal ligament-derived mesenchymal stromal cell sheet product (TWP-0001)
Single transplantation adjust to the defect size
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Periodontitis, consisting of 1 wall intrabony defect, Class III furcation defect, or horizontal defect, with probing depths of 4 - 9 mm after the initial therapy
Key exclusion criteria
maxillary Class III furcation
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Iwata |
Organization
Tokyo Medical and Dental University
Division name
Graduate School, Department of Periodontology
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
0358035488
iwata.peri@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Iwata |
Organization
Tokyo Medical and Dental University
Division name
Graduate School, Department of Periodontology
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
0358035488
Homepage URL
http://www.twmu.ac.jp/upimg/files/20181002iwata2.pdf
iwata.peri@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental 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
Tokyo Women's Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Tokyo Medical and Dental University, Dental Hospital
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-4672
chikadm@tmd.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
東京女子医科大学病院（東京都）、東京医科歯科大学歯学部付属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 28 | 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
6
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 05 | 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
| 2018 | Year | 09 | Month | 28 | Day |
Last modified on
| 2019 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039083
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
