UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020398
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

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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 Kazuto
Middle name
Last name Okabe

Organization

Nagoya University Hospital

Division name

Department of Oral and Maxillofacial Surgery

Zip code

466-8560

Address

65 Tsurumai-cho, Showa-ku, Nagoya

TEL

052-744-2111

Email

kokabe@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

052-744-2942

Homepage URL


Email

s-shimizu@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Hospital

Institute

Department

Personal name



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

https://bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-019-0753-1

Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

4

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

Terminated

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 13 Day

Date of closure to data entry

2022 Year 04 Month 13 Day

Date trial data considered complete

2022 Year 05 Month 25 Day

Date analysis concluded

2022 Year 11 Month 07 Day


Other

Other related information



Management information

Registered date

2015 Year 12 Month 29 Day

Last modified on

2023 Year 02 Month 23 Day



Link to view the page

Value
https://center6.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