UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014211 |
|---|---|
| Receipt number | R000016555 |
| Scientific Title | A study on the effects of culture supernatant of human somatic stem cells on liver cirrhosis |
| Date of disclosure of the study information | 2014/06/10 |
| Last modified on | 2019/06/13 16:34:23 |
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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 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 stem cells on liver cirrhosis
Region
| Japan |
Condition
Condition
Liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety and improvement of clinical symptom and data
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety;
Evaluation of adverse events of clinical symptoms and data
Key secondary outcomes
Efficacy;
Subjective symptoms; general fatigue, itching, abdominal fullness, cramp in the legs
Objective signs; hepatic coma, ascites, edema, bleeding tendency
Laboratory data; AST, ALT, T-Bil, PT, Plt, Alb, P-III-P, Type IV collagen 7S, hyaluronic acid
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 administration of 10ml of culture supernatant of human somatic stem cells once a week, 4 times
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 within the previous one month, and it is anticipated that the treatment will not be changed within the next one month.
-Patients with T-bil < 5mg/dl and serum Alb <= 3.5g/dl.
Key exclusion criteria
-Patients with malignant diseases
-patients with hepatic coma
-Patients with serum Cr >= 2mg/dl
-Patients with HIV infection
-Patients with autoimmune diseases
-Patients who had bleeding from esophageal or gastric varices within the previous 3 months
-Patients with severe organ dysfunction
-Patients infected with unknown microbe
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazumasa Hiroishi, MD |
Organization
Shin-yurigaoka General Hospital
Division name
Department of Gastroenterology
Zip code
Address
255 Furusawa, Asao-ku, Kawasaki, Kanagawa, Japan
TEL
044-322-9991
kazumasa.hiroishi@mt.strins.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumasa Hiroishi, MD |
Organization
Shin-yurigaoka General Hospital
Division name
Department of Gastroenterology
Zip code
Address
255 Furusawa, Asao-ku, Kawasaki, Kanagawa, Japan
TEL
044-322-9991
Homepage URL
kazumasa.hiroishi@mt.strins.or.jp
Sponsor or person
Institute
Shin-yurigaoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
Quarryymen Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 06 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2019 | 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 | 06 | Month | 09 | Day |
Last modified on
| 2019 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016555
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
