UMIN-CTR Clinical Trial

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
Email	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
Email	iwata.peri@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental 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	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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039083