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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001606
Receipt No. R000001927
Scientific Title Clinical trial of the new treatment for osteonecrosis of lunate bone using autologous bone marrow stromal cells
Date of disclosure of the study information 2008/12/27
Last modified on 2020/01/06

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Basic information
Public title Clinical trial of the new treatment for osteonecrosis of lunate bone 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 of lunate bone 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 Lunate bone
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 lunate bone
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 -no one is 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:10000000 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 (Lichtman classification;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 Junya
Middle name
Last name Toguchida
Organization Institute for Frontier Medical Sciences, Kyoto University
Division name Department of Tissue Regeneration
Zip code 606-8507
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 Izumi
Middle name
Last name Hashimoto
Organization Kyoto University Hospital
Division name Department of Orthopaedic Surgery
Zip code 606-8501
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 Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.ac.jp

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
2008 Year 12 Month 27 Day

Related information
URL releasing protocol no protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/28274511
Number of participants that the trial has enrolled 5
Results Progression of radiographic stage (Lichtman
classification)was not recognized in all cases.
Average Stahl's index was decreased.
Average bone volume was decreased.
Results date posted
2020 Year 01 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2017 Year 05 Month 06 Day
Baseline Characteristics stage 3A and 3B
Participant flow Recruited from outpatient
Adverse events No Adverse Event
Outcome measures modified Mayo Wrist Score
Stahl's index
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2007 Year 08 Month 01 Day
Date of IRB
2007 Year 08 Month 01 Day
Anticipated trial start date
2007 Year 08 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
2014 Year 05 Month 01 Day
Date trial data considered complete
2014 Year 05 Month 01 Day
Date analysis concluded
2014 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 12 Month 27 Day
Last modified on
2020 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001927

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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