UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000649 |
|---|---|
| Receipt number | R000000713 |
| Scientific Title | Treatment of bone diseases with porous ceramics integrated with autologous bone marrow derived mesenchymal cells |
| Date of disclosure of the study information | 2007/04/01 |
| Last modified on | 2012/03/23 17:59:20 |
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Basic information
Public title
Treatment of bone diseases with porous ceramics integrated with autologous bone marrow derived mesenchymal cells
Acronym
Porous ceramics with autologous mesenchymal cells for bone diseases(MCTRP0301)
Scientific Title
Treatment of bone diseases with porous ceramics integrated with autologous bone marrow derived mesenchymal cells
Scientific Title:Acronym
Porous ceramics with autologous mesenchymal cells for bone diseases(MCTRP0301)
Region
| Japan |
Condition
Condition
massive bone defects, fracture non-union
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of the treatment of bone defects with interconnected-porous ceramics integrated with autologous bone marrow derived mesenchymal cells for the patients with benign bone tumors or tumor-like conditions of bone
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Periodical evaluation of osseous integration by plain X-ray (radiographic evaluation for ceramic bone substitute proposed by Myoui, et al.) Adverse events (National Cancer Institute Common Toxicity Criteria Ver. 2, Japanese version, JCOG version)
Key secondary outcomes
Overall judgment by multimodal imaging, quantitative radiopacity by aluminum step, BMD by DEXA, histological evaluation, functional evaluation, QOL assessment by SF-36
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
Mesenchymal stem cells that are culture-expanded from bone marrow aspirates are integrated to interconnected porous ceramics and osteoblastic differentiation is induced to generate "cultured bone" - a living bone substitute. The cultured bone is implanted to bone void after the removal of bone tumor.
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
Patients with benign bone tumors or tumor-like conditions of bone
Key exclusion criteria
Active local infection
Serious complications including malignancies
Diabetes
Dialysis for renal failure
Under the influence of steroids or other drugs that affect bone metabolism
Infectious diseases (HIV, HBV, HCV, HTLV, syphilis)
Pregnancy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Yoshikawa |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Orthopedics
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3552
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Myoui |
Organization
Osaka University Hospital
Division name
Medical Center for Translational Research
Zip code
Address
2-15 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-6551
Homepage URL
Sponsor or person
Institute
Osaka University Graduate School of Medicine, Department of Orthopedics
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka University Hospital, Medical Center for Translational Research
National Institute of Advanced Industrial Science and Technology, Research Institute for Cell Engineering
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2003 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 03 | Month | 22 | Day |
Last modified on
| 2012 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000713
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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