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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001601
Receipt No. R000001921
Scientific Title Clinical trial of the new treatment for osteonecrosis using autologous bone marrow stromal cells
Date of disclosure of the study information 2008/12/26
Last modified on 2014/06/27

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Basic information
Public title Clinical trial of the new treatment for osteonecrosis using autologous bone marrow stromal cells
Acronym Clinical trial for osteonecrosis using autologous bone marrow stromal cells
Scientific Title Clinical trial of the new treatment for osteonecrosis using autologous bone marrow stromal cells
Scientific Title:Acronym Clinical trial for osteonecrosis using autologous bone marrow stromal cells
Region
Japan

Condition
Condition Osteonecrosis of the Femoral Head
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze the safety and efficacy of mesenchymal stem cell transplantation for osteonecrosis of femoral head
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes X-ray evaluation of clinical stage on the point of preoperation and two years after operation
Key secondary outcomes Clinical score and bone volume on the point of preoperation, one year after operaion and two years after operation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Period: 2 years
Volume:50000000 of mesenchymal stem cell
Number:1
Case number intervention: 10 cases
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
60 years-old >
Gender Male and Female
Key inclusion criteria Clinical stage of Xray evaluation:Stage 3A and Stage 3B
Key exclusion criteria Previous medical history against candidate bone
Heavy smorker (Brinkman index>600)
Warfarin treatment
Diabetes mellitus (HbA1c>9.0%)
Arteriosclerosis obliterans
Pregnancy,during lactation
Malignant neoplasm
Cardiac infarction, brain infaction
Rheumatoid arthritis
Dialytic therapy
Complication of blood disease
Live less than 12 months
Active infection
Hypotension(systolic blood pressure<90mmHg)
Low body weight(under 40kg)
Bone marrow dysfunction (neutrophil<1500/mm3, Hb<11.0g/dL(male),Hb<10.0g/dL(women), Plt<100000/mm3)
Patient with the anti-osteoporosis drug and steroid were changed within 3 months
Patient which was judged as inadequate
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junya Toguchida
Organization Institute for Frontier Medical Sciences, Kyoto University
Division name Department of Tissue Regeneration
Zip code
Address 53 Kawahara-cho Shogoin Sakyo-ku Kyoto City
TEL 075-751-4134
Email togjun@frontier.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Izumi Hashimoto
Organization Kyoto University Hospital
Division name Department of Orthopaedic Surgery
Zip code
Address 54 Kawahara-cho Shogoin Sakyo-ku Kyoto city
TEL 075-751-4400
Homepage URL http://www.kuhp.kyoto-u.ac.jp/~seikeigeka/
Email seikei@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Orthopedic Surgery, Kyoto University Hospital
Institute
Department

Funding Source
Organization Kyoto University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Center for Cell and Molecular Therapy, Kyoto University
Name of secondary funder(s) Ministry of Health, Labor, and Welfare Ministry of Education, Culture, Sports, Science, and Technology
New Energy and Industrial Technology Development Organization

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 京都大学医学部附属病院 
Kyoto University Hospital

Other administrative information
Date of disclosure of the study information
2008 Year 12 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/24593258
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
2007 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2007 Year 08 Month 01 Day
Last follow-up date
2011 Year 07 Month 01 Day
Date of closure to data entry
2011 Year 07 Month 01 Day
Date trial data considered complete
2012 Year 03 Month 01 Day
Date analysis concluded
2012 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 12 Month 26 Day
Last modified on
2014 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001921

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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