UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000649
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Osaka University Graduate School of Medicine, Department of Orthopedics
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000713

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.