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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000605
Receipt No. R000000717
Scientific Title Clinical study on custom-made bone implants alpha-TCP-based novel bone implants with geometry that fits bone defects and internal structures efficient for bone tissue regeneration
Date of disclosure of the study information 2007/02/09
Last modified on 2007/10/26

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Basic information
Public title Clinical study on custom-made bone implants alpha-TCP-based novel bone implants with geometry that fits bone defects and internal structures efficient for bone tissue regeneration
Acronym Clinical study on custom-made bone implants
Scientific Title Clinical study on custom-made bone implants alpha-TCP-based novel bone implants with geometry that fits bone defects and internal structures efficient for bone tissue regeneration
Scientific Title:Acronym Clinical study on custom-made bone implants
Region
Japan

Condition
Condition Congenital, traumatic, post-operative or tumorous defects/deformations of unloaded bones in cranio-maxillofacial areas and limbs and trunks
Classification by specialty
Orthopedics Radiology Oral surgery
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm clinical safety and efficacy of custom made bone implants (3DB-01) based on alpha-TCP, which has been safely used in clinical settings
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Confirmation of safety and efficacy of custom-made bone implants (3DB-01)
Key secondary outcomes

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
Device,equipment Maneuver
Interventions/Control_1 Artificial bones molded by ink-jet printing techniques are implanted to congenital, traumatic, post-operative or tumorous defects/deformations of unloaded bones in cranio-maxillofacial areas and limbs and trunks
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
6 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria Cases with congenital, traumatic, post-operative or tumorous defects/ deformations of unloaded bones in cranio-maxillofacial areas and limbs and trunks
Key exclusion criteria 1) Patients with complications including abnormal calcium metabolism or serious cardiac, hepatic or renal dysfunctions (grade 2 and grade 3 in the complication category)

2) Patients who have less-than-one-year prognoses of complications
3) Patients with severe complications who are not expected to endure tests necessary for clinical follow-up.
4) Patients with infections that may relapse.
5) Patients with collagen diseases.
6) Patients with histories of alcohol or drug dependency within the past 3 months
7) Patients with malignant neoplasms
8) Patients with possibile malignant neoplasms
9) Patients with proliferative diabetic retinopathy
10) Pregnant women, women suspected of being pregnant and breast-feeding women
11) Patients who cannot observe the instruction not to inflict excessive forces and burdens on affected areas after implantation and patients with mental disorders.
12) Patients who do not give informed consents
13) Patients who are judged to be inappropriate for the study by doctors in charge.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Takato
Organization The University of Tokyo Hospital
Division name Division of Tissue Engineering
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
TEL 03-3815-5411(33714)
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Tei/Ung-il Chung
Organization The University of Tokyo Hospital
Division name Division of Tissue Engineering
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
TEL 03-3815-5411(37014)
Homepage URL
Email uiching-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital Division of Tissue Engineering
Institute
Department

Funding Source
Organization Funding for Development of Highly-advanced Medical Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2007 Year 02 Month 09 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
Date of protocol fixation
2006 Year 01 Month 19 Day
Date of IRB
Anticipated trial start date
2006 Year 03 Month 01 Day
Last follow-up date
2008 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 02 Month 09 Day
Last modified on
2007 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000717

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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