UMIN-CTR Clinical Trial

Basic information
Public title	Alveolar bone regeneration therapy using autologous bone marrow stromal cells
Acronym	Alveolar bone regenration using bone marrow stromal cells
Scientific Title	Alveolar bone regeneration therapy using autologous bone marrow stromal cells
Scientific Title:Acronym	Alveolar bone regenration using bone marrow stromal cells
Region	Japan

Condition
Condition	Alveolar bone atrophy
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of bone regeneration therapy using autologous bone marrow stromal cells for the patients with severe alveolar bone atrophy. The usefulness of modified and automated cell culture process will be also assessed.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Bone area from biopsy samples: Non-decalcified tissue section from bone biopsy sample will be used and the areas for new bone, remaining beta-TCP, bone marrow, fibrous conective tissue will be analyzed.
Key secondary outcomes	Safety: Presence of adverse events during treatment period under the protocol. Newly formed bone volume: CT data will be analyzed and the volume of newly formed bone will be calculated. The hight of bone at the implant installation site will be also analyzed. Osseointegration of Implant. Failure of implant

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	Maneuver
Interventions/Control_1	Transplantation of tissu-engineered bone.
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects were patients who planned to receive dental implant treatment. These subjects had continuous tooth defects (more than 2), where fixed prostheses were not applicable. The subjects voluntarily enrolled in this study and wished to have dental implant treatment rather than conventional removable prostheses. Subjects showed severely atrophic maxilla or mandible, which require bone transplantation. The width of alveolar bone at the installation sites was less than 5 mm. In the maxilla, the distance between the alveolar ridge and the sinus floors was less than 5 mm. Similarly, in the mandible, the distance between the ridge and mandibular canal was less than 5 mm. Good oral hygiene was maintained. Tooth brushing instruction and scaling were performed prior to the protocol treatment. The age of the subjects was limited to 20 -70 years. The subjects were able to understand and agreed to receive the treatment by informed consent.
Key exclusion criteria	Patients with diabetes and/or autoimmune diseases, who presented hemorrhagic diathesis where partial thromboplastin time (PT) was lower than 50% and activated partial thromboplastin time (APTT) less than 23.5 or longer than 42.5 seconds, uncontrollable infectious diseases, patients with osteoporosis who are prescribed bisphosphonate, liver dysfunction with a Glutamic Oxaloacetic Transaminase (GOT) value less than 10 or more than 40 IU/L or with a glutamic pyruvic transaminase (GPT) less than 5 or more than 45 IU/L, pregnant or possible pregnancy, allergy to any of the medications used in this study and/or the presence of allergy that required continuous systemic medication, smokers, subjects who are positive for HBs antigen (CLIA), HBs antibody (CLIA), HBc antigen (CLIA), HCV antibody (RIA solid phase), HIV antigen and HIV antibody (ELISAs), syphilis serology (RPR), syphilis serology (TPHA) and HTLV-1 and other special conditions that the responsible physician considered not appropriate were excluded.
Target sample size	3

Research contact person
Name of lead principal investigator	1st name Hideaki Middle name Last name HiKagami
Organization	Matsumoto Dental University
Division name	Department of Oral and Maxillofacial Surgery
Zip code	399-0781
Address	1780 Hirooka, Gobara, Shiojiri 399-0781, Japan
TEL	0263-51-2066
Email	hideaki.kagami@mdu.ac.jp

Public contact
Name of contact person	1st name Hideaki Middle name Last name Kagami
Organization	Matsumoto Dental University
Division name	Institute of Oral Science
Zip code	3990781
Address	HirookaGobara
TEL	0263512055
Homepage URL
Email	hideaki.kagami@mdu.ac.jp

Sponsor
Institute	Matsumoto Dental University Hospital
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Matsumoto Dental University Ethical Committee
Address	1789 Hirooka Gobara, Shiojiri, Nagano, Japan
Tel	0263-51-2188
Email	daisuke.hayakawa@mdu.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	松本歯科大学病院

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 22 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	3
Results	So far, we have recruited 3 patients and cell transplantation was performed to the bone defect sites. Bone biopsy has been performed for 2 patients and dental implants were installed. One of the patients finished the protocol treatment. One of the patients was discontinued due to the circumstances of patient.
Results date posted	2020 Year 02 Month 29 Day
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	Terminated
Date of protocol fixation	2018 Year 03 Month 09 Day
Date of IRB	2017 Year 03 Month 10 Day
Anticipated trial start date	2018 Year 08 Month 24 Day
Last follow-up date	2024 Year 03 Month 08 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 08 Month 21 Day
Last modified on	2022 Year 01 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038595