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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020398
Receipt No. R000016543
Scientific Title Regenerative medicine using bone marrow-derived mesenchymal cells for maxillomandibular bone defect.
Date of disclosure of the study information 2016/01/15
Last modified on 2020/08/26

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Basic information
Public title Regenerative medicine using bone marrow-derived mesenchymal cells for maxillomandibular bone defect.
Acronym Tissue-Engineered Osteogenic Material for maxillomandibular bone defect (TEOM).
Scientific Title Regenerative medicine using bone marrow-derived mesenchymal cells for maxillomandibular bone defect.
Scientific Title:Acronym Tissue-Engineered Osteogenic Material for maxillomandibular bone defect (TEOM).
Region
Japan

Condition
Condition Bone defect resulting from maxillofacial injury, tumor/cyst removal in maxillomandibular regionr
Classification by specialty
Surgery in general Oral surgery Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of bone regeneration using bone marrow-derived mesenchymal cells in patients with bone defect resulting from maxillofacial injury, tumor/cyst removal in maxillomandibular region.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Rate of procedure sites with successful bone regeneration
Key secondary outcomes 1)Regenerated bone height
2)Percentage of the regenerated bone height over the height of the initial defect
3)CT value
4)Rate of successful implant placement
5)Time from transplantation to implant placement
6)Survival rate and time of implant
7)Tooth mobility
8)Masticatory force
9)Histological assessment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment Other
Interventions/Control_1 Transplantation of bone marrow-derived mesenchymal cells, platelet rich plasma, thrombin, calcium chloride and beta-TCP.
Interventions/Control_2 Transplantation of platelet rich plasma, thrombin, calcium chloride and beta-TCP.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients who require bone regeneration satisfying all of the inclusion criteria below:
>=20-year-old patients who have a maxillomandibular bone defect that lies over 1/3 of the maxillomandibular area with remaining bone of <=10 mm in height due to maxillofacial injury or tumor/cyst removal (Patients who had surgical tumor removal in maxillomandibular region must not have relapse/metastasis for 5 year of observation period after the procedure)
2.Patients who have received plaque control instructions by a dentist or a dental hygienist and are in a good management of it
3.Patients who are willing and able to give signed consent
Key exclusion criteria 1. Patients with bone defect as a result of periodontitis
2. Patients for whom surgical procedure is prohibited e.g, severe heart disease, congenital coagulation factor deficiency, leukemia, dialysis, end-stage malignant tumor
3. Patients with or with a history of infection
4. Patients with diabetes that is not well-controlled
5. Patients taking bisphosphonates for more than 3 months or denosumab for more than 6 months before the consent
6. Patients with or with a history of malignant tumor
7. Patients taking steroids or immunosuppressive drugs who cannot stop such medication for 4 weeks after trial intervention
8. Patients in a serious condition of certain diseases
9. Patients with difficulty in bone marrow aspiration
10. Patients from whom a sufficient amount of blood cannot be taken for PRP preparation
11. Patients with contraindications to local anesthetics
12. Patients with a history of hypersensitivity to antibiotics, antifungals, thrombin products, or bovine blood-derived products
13. Patients taking hemocoagulase products, tranexamic acid products, or aprotinin products
14. Female patients who are pregnant, suspected to be pregnant, breastfeeding, or those who do not agree to practice contraception
15. Any other patients whom the trial investigator deemed ineligible to this study
Target sample size 29

Research contact person
Name of lead principal investigator
1st name Shinobu
Middle name
Last name Shimizu
Organization Nagoya University Hospital
Division name Department of Oral and Maxillofacial Surgery
Zip code 466-8560
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL +81527442942
Email s-shimizu@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Shinobu
Middle name
Last name Shimizu
Organization Nagoya University Hospital
Division name Department of Advanced Medicine
Zip code 466-8560
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL +81527442942
Homepage URL
Email s-shimizu@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nagoya University Certified Committee for Regenerative Medicine
Address 65 Tsurumai-cho, Showa-ku, Nagoya
Tel 052-744-2479
Email iga-shinsa@adm.nagoya-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 jRCTb041190076
Org. issuing International ID_1 Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 名古屋大学医学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 15 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
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 No longer recruiting
Date of protocol fixation
2015 Year 08 Month 06 Day
Date of IRB
2016 Year 01 Month 22 Day
Anticipated trial start date
2016 Year 05 Month 10 Day
Last follow-up date
2022 Year 04 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 29 Day
Last modified on
2020 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016543

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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