UMIN-CTR Clinical Trial

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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