UMIN-CTR Clinical Trial

Basic information
Public title	A study on the effects of culture supernatant of human somatic stem cells on liver cirrhosis
Acronym	The effects of culture supernatant of human somatic stem cells on liver cirrhosis
Scientific Title	A study on the effects of culture supernatant of human somatic stem cells on liver cirrhosis
Scientific Title:Acronym	The effects of culture supernatant of human somatic stem cells on liver cirrhosis
Region	Japan

Condition
Condition	Liver cirrhosis
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the safety and efficacy of culture supernatant of human somatic stem cells on liver cirrhosis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety: Adverse events and laboratory tests
Key secondary outcomes	Efficacy: Clinical symptoms and laboratory tests

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intravenous or intranasal administration of culture supernatant of human somatic stem cells
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with liver cirrhosis under treatment Treatment has not been changed in the previous month and it is anticipated that the treatment will not be changed in the next month Patients with T-bil less than 5mg/dl and serum Alb less than or equal 3.5g/dl
Key exclusion criteria	Patients with malignant diseases
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Hiroshi Middle name Last name Terunuma
Organization	Tokyo Clinic
Division name	Internal Medicine
Zip code	100-0004
Address	1F Shin-Otemachi Building, 2-2-1 Otemachi, Chiyoda-ku, Tokyo, 100-0004, Japan
TEL	03-3516-7165
Email	terunuma.h@gmail.com

Public contact
1st name of contact person	1st name Hiroshi Middle name Last name Terunuma
Organization	Tokyo Clinic
Division name	Internal Medicine
Zip code	100-0004
Address	1F Shin-Otemachi Building, 2-2-1 Otemachi, Chiyoda-ku, Tokyo, 100-0004, Japan
TEL	03-3516-7165
Homepage URL
Email	terunuma.h@gmail.com

Sponsor
Institute	Tokyo Clinic
Institute
Department

Funding Source
Organization	Tokyo Clinic
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	Tokyo General Hospital IRB
Address	3-15-2 Egota, Nakano-ku, Tokyo
Tel	03-3387-5421
Email	t.kaneko@minos.ocn.ne.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	東京クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 29 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	2013 Year 11 Month 28 Day
Date of IRB	2013 Year 11 Month 26 Day
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 10 Month 29 Day
Last modified on	2019 Year 05 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018075