Unique ID issued by UMIN | UMIN000020398 |
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Receipt number | 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 | 2023/02/23 13:38:54 |
Regenerative medicine using bone marrow-derived mesenchymal cells for maxillomandibular bone defect.
Tissue-Engineered Osteogenic Material for maxillomandibular bone defect (TEOM).
Regenerative medicine using bone marrow-derived mesenchymal cells for maxillomandibular bone defect.
Tissue-Engineered Osteogenic Material for maxillomandibular bone defect (TEOM).
Japan |
Bone defect resulting from maxillofacial injury, tumor/cyst removal in maxillomandibular regionr
Surgery in general | Oral surgery | Dental medicine |
Others
NO
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.
Efficacy
Exploratory
Phase II
Rate of procedure sites with successful bone regeneration
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Central registration
2
Treatment
Medicine | Device,equipment | Other |
Transplantation of bone marrow-derived mesenchymal cells, platelet rich plasma, thrombin, calcium chloride and beta-TCP.
Transplantation of platelet rich plasma, thrombin, calcium chloride and beta-TCP.
20 | years-old | <= |
Not applicable |
Male and Female
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
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
29
1st name | Kazuto |
Middle name | |
Last name | Okabe |
Nagoya University Hospital
Department of Oral and Maxillofacial Surgery
466-8560
65 Tsurumai-cho, Showa-ku, Nagoya
052-744-2111
kokabe@med.nagoya-u.ac.jp
1st name | Shinobu |
Middle name | |
Last name | Shimizu |
Nagoya University Hospital
Department of Advanced Medicine
466-8560
65 Tsurumai-cho, Showa-ku, Nagoya
052-744-2942
s-shimizu@med.nagoya-u.ac.jp
Nagoya University Hospital
AMED
Japanese Governmental office
Nagoya University Certified Committee for Regenerative Medicine
65 Tsurumai-cho, Showa-ku, Nagoya
052-744-2479
iga-shinsa@adm.nagoya-u.ac.jp
YES
jRCTb041190076
Japan Registry of Clinical Trials
名古屋大学医学部附属病院(愛知県)
2016 | Year | 01 | Month | 15 | Day |
https://bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-019-0753-1
Unpublished
4
Terminated
2015 | Year | 08 | Month | 06 | Day |
2016 | Year | 01 | Month | 22 | Day |
2016 | Year | 05 | Month | 10 | Day |
2022 | Year | 04 | Month | 13 | Day |
2022 | Year | 04 | Month | 13 | Day |
2022 | Year | 05 | Month | 25 | Day |
2022 | Year | 11 | Month | 07 | Day |
2015 | Year | 12 | Month | 29 | Day |
2023 | Year | 02 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016543
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