UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study of alveolar bone tissue engineering using autologous bone marrow stromal cells
Title of the study (Brief title)	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	Hideaki Kagami
Organization	IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Division name	Department of General Medicine
Address	4-6-1, Shirokanedai, Minato-ku, Tokyo 108-8639, Japan
TEL	+81-3-5449-5120
Email	kagami@ims.u-tokyo.ac.jp

Public contact
Name of contact person	Hideaki Kagami
Organization	IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Division name	Department of General Medicine
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
Email	kagami@ims.u-tokyo.ac.jp

Sponsor
Institute	IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Institute
Department

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.

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 03 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007387