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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034310
Receipt No. 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 2018/09/28

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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
Middle name
Last name Takanori Iwata
Organization Tokyo Women's Medical University
Division name Institute of Advanced Biomedical Engineering and Science, and Department of Oral and Maxillofacial Surgery
Zip code
Address 8-1 Kawada-cho Shinjuku-ku Tokyo 162-8666 Japan
TEL 03-3353-8111
Email iwata.takanori@twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takanori Iwata
Organization Tokyo Women's Medical University
Division name Institute of Advanced Biomedical Engineering and Science, and Department of Oral and Maxillofacial S
Zip code
Address 8-1 Kawada-cho Shinjuku-ku Tokyo 162-8666 Japan
TEL 03-3353-8111
Homepage URL
Email iwata.takanori@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Department of Oral and Maxillofacial Surgery
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 Tokyo Medical and Dental University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
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
2018 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.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


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