UMIN-CTR Clinical Trial

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

Pulmonary hypertension

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kanazawa University

Institute

Department

Personal name

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2018

Year

06

Month

01

Day

Last modified on

2018

Year

12

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037372