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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032832
Receipt No. R000037372
Scientific Title The role of mesenchymal stem cells in peripheral blood in patients with pulmonary hypertension.
Date of disclosure of the study information 2018/06/01
Last modified on 2018/12/01

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Basic information
Public title The role of mesenchymal stem cells in peripheral blood in patients with pulmonary hypertension.
Acronym The role of mesenchymal stem cells in peripheral blood in patients with pulmonary hypertension.
Scientific Title The role of mesenchymal stem cells in peripheral blood in patients with pulmonary hypertension.
Scientific Title:Acronym The role of mesenchymal stem cells in peripheral blood in patients with pulmonary hypertension.
Region
Japan

Condition
Condition Pulmonary hypertension
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the role of mesenchymal stem cells in peripheral blood in pulmonary hypertension.
Basic objectives2 Others
Basic objectives -Others Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between severity of pulmonary hypertension and the frequency of mesenchymal stem cells in peripheral blood.
Key secondary outcomes The relationship between the frequency of mesenchymal stem cells in peripheral blood and prognosis of pulmonary hypertension.

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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients diagnosed with pulmonary hypertension
2.Patients who have a history of hospitalization for evaluation of pulmonary hypertension
3.Patients who can continue to receive treatment of pulmonary hypertension in outpatient clinic
4.Patients who agreed to participate in this study
Key exclusion criteria 1.Patients with active infectious diseases and inflammatory diseases
2.Patients with fatal acute diseases such as acute coronary syndrome or acute pulmonary embolism
3.Patients with blood disorders
4.Pregnant women and patients who may become pregnant in the future
5.Patients with cancer and under chemotherapy and/or radiotherapy
6.Patients who the doctor considers inappropriate as subject of this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuichi Kaneko
Organization Kanazawa University Graduate School of Advanced Preventive Medical Sciences
Division name Department of System Biology
Zip code
Address 13-1 Takara-machi, Kanazawa
TEL 076-265-2238
Email chiaki_goten_j_17th@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miyake Yasuko
Organization Kanazawa University
Division name Innovative Clinical Research Center
Zip code
Address 13-1 Takara-machi, Kanazawa
TEL 076-265-2048
Homepage URL
Email crc.irb-knz@esct.jp

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 06 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 Eleven PAH patients were examined. The frequency of CD271 positive cells was significantly higher in severe PAH than that in mild PAH and non-PAH patients. The frequency of CD271 positive cells is also might be related to severity of Pulmonary Vascular Resistance and Cardiac index.
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
2016 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients by whom an informed consent is obtained are enrolled and undergo the following examinations;
1.Peripheral blood collection at the time of admission of first time and follow-up observation
2.Flow cytometric analysis, Microarray analysis/quantitative PCR and ELISA are performed to examine the cell surface markers, gene expression and protein level of cytokines in peripheral blood, respectively.
3,The examination for the assessment of severity of pulmonary hypertension such as cardiac echocardiography, right heart catheterization, respiratory function test, and 6-minute walking test.

Management information
Registered date
2018 Year 06 Month 01 Day
Last modified on
2018 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037372

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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