UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033847 |
|---|---|
| Receipt number | 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 | 2022/01/25 11:10:36 |
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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
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
hideaki.kagami@mdu.ac.jp
Sponsor or person
Institute
Matsumoto Dental University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038595
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