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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033847
Receipt No. R000038595
Scientific Title Alveolar bone regeneration therapy using autologous bone marrow stromal cells
Date of disclosure of the study information 2018/08/22
Last modified on 2020/02/29

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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. Now we are observing the outcome.
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 No longer recruiting
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
2020 Year 02 Month 29 Day


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

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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