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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000015618
Receipt No. R000018152
Scientific Title Research that focus on Multiliniage-differentiating stress enduring cells(Muse cells) for the treatment with mesenchymal stem cells in acute severe diseases
Date of disclosure of the study information 2014/11/07
Last modified on 2017/05/09

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Basic information
Public title Research that focus on Multiliniage-differentiating stress enduring cells(Muse cells) for the treatment with mesenchymal stem cells in acute severe diseases
Acronym Research for Muse cells in acute severe diseases
Scientific Title Research that focus on Multiliniage-differentiating stress enduring cells(Muse cells) for the treatment with mesenchymal stem cells in acute severe diseases
Scientific Title:Acronym Research for Muse cells in acute severe diseases
Region
Japan

Condition
Condition sepsis, trauma, burn, post-cardiac arrest syndrome, rhabdomyolysis
Classification by specialty
Surgery in general Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal the Muse cells kinetics in acute severe diseases and to research the potential of cell-based therapy for acute invasive pathology by analyzing relationship Muse cells with outcome, severity, and damage-associated molecular patterns and inflammatory mediators from the aspects of function as repair cells and the trophic effects
Basic objectives2 Others
Basic objectives -Others Exploration
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes We evaluate the Muse cells in acute severe diseases. 1) Quantitative assessment of peripheral blood Muse cells: the quantification by flow cytometry, 2) Isolation of Muse cells, culture, form / function analysis
In addition, it clarifies the association the dynamics of Muse cells with outcome, severity and damage-associated molecular patterns and inflammatory mediators.
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria a)Of the patients who were hospitalized in the Tohoku University Hospital Emergency center, trauma; Abbreviated Injury Score (AIS) 3 or more, burn; total burn surface area(TBSA) more than 10%, sepsis; severe sepsis, rhabdomyolysis; CK 5,000 or more, post-cardiac arrest syndrome; out-of-hospital cardiac arrest patients requiring hospital treatment with return of spontaneous circulation by resuscitation
b)healthy person
Key exclusion criteria Patients or family do not agree to participate in this study.
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Shigeki Kushimoto
Organization Tohoku University Graduate School of Medicine
Division name Division of Emergency and Critical Care Medicine
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL 022-717-7489
Email information@emergency-medicine.med.thoku.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Tetsuya Sato
Organization Tohoku University Graduate School of Medicine
Division name Division of Emergency and Critical Care Medicine
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL 022-717-7489
Homepage URL
Email t23jor@med.tohoku.ac.jp

Sponsor
Institute Division of Emergency and Critical Care Medicine, Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Stem Cell Biology and Histology, Tohoku University Graduate School of Medicine
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
2014 Year 11 Month 07 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 Enrolling by invitation
Date of protocol fixation
2014 Year 11 Month 05 Day
Date of IRB
Anticipated trial start date
2014 Year 12 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 Blood is collected within 24 hours after the visit, 48 hours, 72 hours, day 7, day 14, day28 or before discharge. We evaluate the dynamics of Muse cells, and consider the relationship with the patient background factors, severity score, damage-associated molecular patterns, inflammatory mediators, fibrinolytic system parameters, and cell mediated immunity.

Management information
Registered date
2014 Year 11 Month 06 Day
Last modified on
2017 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018152

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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