UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045309 |
|---|---|
| Receipt number | R000051458 |
| Scientific Title | The clinical study of alveolar bone tissue engineering for severely atrophic alveolar bone using autologous bone marrow stromal cells |
| Date of disclosure of the study information | 2021/08/31 |
| Last modified on | 2022/03/01 14:19:08 |
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Basic information
Public title
The clinical study of alveolar bone tissue engineering for severely atrophic alveolar bone using autologous bone marrow stromal cells
Acronym
Alveolar bone regeneration using bone marrow stromal cells
Scientific Title
The clinical study of alveolar bone tissue engineering for severely atrophic alveolar bone using autologous bone marrow stromal cells
Scientific Title:Acronym
Alveolar bone regeneration using bone marrow stromal cells
Region
| Japan |
Condition
Condition
severely atrophic alveolar bone
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of bone tissue engineering for patients with severely atrophic alveolar bone using autologous bone marrow stromal cells and long-term follow-up.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of alveolar bone regeneration assessing by CT images 6 months and over 5 years after the transplantation.
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
bone marrow cell harvest - cell cultured bone transplantation
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 showed severely atrophic maxilla or mandible, which require bone transplantation for dental implant insertion. 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.
Key exclusion criteria
Patients with diabetes and/or autoimmune diseases,
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Asahina |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Regenerative Oral Surgery
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7701
asahina@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Asahina |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Regenerative Oral Surgery
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7701
Homepage URL
asahina@nagasaki-u.ac.jp
Sponsor or person
Institute
Institute of Medical Sciences, University of Toikyo
Institute
Department
Personal name
Funding Source
Organization
Self-sustaining
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Medical Sciences, University of Toikyo
Address
4-6-1 Shiroganedai, Minato-ku, Tokyo
Tel
03-6409-2035
tokikoni@ims.u-tokyo.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f3.cgi
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2077-0383/10/22/5231
Number of participants that the trial has enrolled
8
Results
The osteoblastic cells induced from bone marrow were transplanted with autologous platelet rich plasma and b-tricalcium phosphate granules onto severely atrophic maxillary bone. Eight patients were enrolled. Radiographic evaluation and bone biopsies showed bone regeneration in all patients with the average bone area of 41.9%. No side effects were noted. The results showed that bone tissue engineering was safe and feasible.
Results date posted
| 2021 | Year | 08 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 11 | Month | 22 | Day |
Baseline Characteristics
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.
Participant flow
10 patients were enrolled. One was dropped out due to insufficient cell growth, another one was also dropped out because bacterial contamination into auto-serum was suspected. 8 subjects were followed up 2 years after transplantation, and 5 out of 8 subjects were followed up over 5 years.
Adverse events
No adverse events were observed.
Outcome measures
1. safety: occurance of adverse events
2. celtured cell: cell number, alkaline phosphatase activity
3. bone formation: volume calculated from CT images, histomorphometric analysis of bone biopsy specimen
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 30 | Day |
Last modified on
| 2022 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051458
