UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006255 |
|---|---|
| Receipt number | R000007387 |
| Scientific Title | A clinical study of alveolar bone tissue engineering using autologous bone marrow stromal cells |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2018/09/07 10:05:06 |
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Basic information
Public title
A clinical study of alveolar bone tissue engineering using autologous bone marrow stromal cells
Acronym
A clinical study of alveolar bone tissue engineering
Scientific Title
A clinical study of alveolar bone tissue engineering using autologous bone marrow stromal cells
Scientific Title:Acronym
A clinical study of alveolar bone tissue engineering
Region
| Japan |
Condition
Condition
Atrophy of alveolar bone
Classification by specialty
| Oral surgery | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the efficacy and the safety of alveolar bone tissue engineering using granular scaffolds and optimally cultured/induced autologous bone marrow stromal cells.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I
Safety
Phase II
Bone area from biopsy samples
Key secondary outcomes
Phase I
Bone area from biopsy samples
Phase II
Safety
Calculated bone volume from computed tomography
Success of osseointegration
Implant failure
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
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Kagami |
Organization
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Division name
Department of General Medicine
Zip code
Address
4-6-1, Shirokanedai, Minato-ku, Tokyo 108-8639, Japan
TEL
+81-3-5449-5120
kagami@ims.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Kagami |
Organization
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Division name
Department of General Medicine
Zip code
Address
4-6-1, Shirokanedai, Minato-ku, Tokyo 108-8639, Japan
TEL
+81-3-5449-5744
Homepage URL
http://www.ims.u-tokyo.ac.jp/hematology/terg/index.html
kagami@ims.u-tokyo.ac.jp
Sponsor or person
Institute
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Research Hospital, The Institute of Medical Science, The University of Tokyo
TES Holdings Co.ltd
Olympus Terumo Biomaterials Corp.
Nobel Biocare Japan K.K.
IRB Contact (For public release)
Organization
Address
Tel
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
東京大学医科学研究所附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 01 | 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
Results
Adverse events:
Evaluation of safety: In terms of the quality control of the product, no problem was observed.
No adverse events related to cell transplantation was observed. The exposure of GBR membrane was observed in 3 cases, which was healed after removal of the membrane and bone regeneration was feasible. Overall, the safety of this protocol was confirmed.
Efficacy: New bone area was identical to that in the preceding our clinical study. Individual variation (cell proliferation and new bone area) was significantly reduced from previous clinical study. All dental implants aquired ossointegration and no failure was observed during the observation period.
Evaluation: The results showed the safety of this protocol. The level of new bone formation was identical to that of the previous clinical study, thus proved the non-inferiority of the current protocol. Since the purpose of this study has achieved from 15 cases, the clinical study was closed without the addition of 10 cases, which was originally planned.
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
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 07 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 07 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 31 | Day |
Last modified on
| 2018 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007387
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