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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010275
Receipt No. R000012030
Scientific Title Evaluation of bone marrow blood transplanted to lunate in Kienbock disease
Date of disclosure of the study information 2013/04/01
Last modified on 2013/03/19

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Basic information
Public title Evaluation of bone marrow blood transplanted to lunate in Kienbock disease
Acronym BMB transplantation for Kienbock disease
Scientific Title Evaluation of bone marrow blood transplanted to lunate in Kienbock disease
Scientific Title:Acronym BMB transplantation for Kienbock disease
Region
Japan

Condition
Condition Kienbock disease
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Analysis of BMC of radius or iliac bone
and Clinical outcome in patients suffered kienbock disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes cell count of inspirated BMB
colony forming unit number after cell culture, CD34 count, Clinical outcome
Key secondary outcomes Clinical outcome

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
16 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria kienbokk disease patients who undergo BMC transplantation
Key exclusion criteria not agree
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuki HARA
Organization Faculty of Medice, University of Tsukuba
Division name depertment of Orthopaedic suregry
Zip code
Address 1-1-1. Tennodai, Tsukuba, Ibaraki, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Faculty of Medice, University of Tsukuba
Division name depertment of Orthopaedic suregry
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Yuki HARA
Institute
Department

Funding Source
Organization Univ Tsukuba
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2013 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 Open public recruiting
Date of protocol fixation
2008 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information colony forming assey
CD34
clinical outcome

Management information
Registered date
2013 Year 03 Month 19 Day
Last modified on
2013 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012030

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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