UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001601 |
|---|---|
| Receipt number | 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 09:26:16 |
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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
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/
seikei@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Orthopedic Surgery, Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
