UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036136 |
|---|---|
| Receipt number | R000024865 |
| Scientific Title | Safty and efficacy of autologuous adipose tissue derived mesenchymal stem cell infusion therapy on liver cirrhosis |
| Date of disclosure of the study information | 2019/03/10 |
| Last modified on | 2020/03/11 04:10:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Safty and efficacy of autologuous adipose tissue derived mesenchymal stem cell infusion therapy on liver cirrhosis
Acronym
Adipose tissue-derived mesenchymal stem cell therapy
Scientific Title
Safty and efficacy of autologuous adipose tissue derived mesenchymal stem cell infusion therapy on liver cirrhosis
Scientific Title:Acronym
Adipose tissue-derived mesenchymal stem cell therapy
Region
| Japan |
Condition
Condition
liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Gastrointestinal surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was planed to elucidate about the safty and efficacy of adipose derived mesenchmal stem theapy for liver cirrhosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
General status, D-dimer, FDP, respiratory function, organ function are evaluated at 1,3.7,14,30,90,and 360 days after infusion of ADSC.
Key secondary outcomes
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
| Maneuver | Other |
Interventions/Control_1
After taking subcutaneous adipose tissue, adpose derived mesencymal stem cell is cultured. Cultured ADSC is infused in the cirrhotic patient autologously.
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.Liver cirrhosis is diagnosed by CT and clinical data
2.>or= 20 years age
3.>or= Child pugh score 6
4.obtained informed consent
Key exclusion criteria
A.alcoholic patients
B.sever heart disease
C.pregnant patients
D.malignant tumor such as HCC
E.uncontrolled infectious disease
F.impossible to obtain an informed consent
I.The patient who primary investigator judged unsuitable
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Akahoshi |
Organization
Kyushu university graduate school of medic
Division name
Disaster and Emergency medicine
Zip code
812-8582
Address
3-1-1,Maidashi, Higashi-ku, Fukuoka, Japan
TEL
0926426223
tomohiko@surg2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | |
| Last name | Akahoshi |
Organization
Department of disaster and emergency medicine
Division name
Department of disaster and emergency medicine
Zip code
812-8582
Address
3-1-1,Maidashi, Higashi-ku, Fukuoka, Japan
TEL
0926426223
Homepage URL
tomohiko@surg2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu university
Institute
Department
Personal name
Funding Source
Organization
Own
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
comittee of regenerative medicine, kyushu university
Address
Higashi-ku, Maidashi, 3-1-1
Tel
0926426223
tomohiko@surg2.med.kyushu-u.ac.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
九州大学病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | 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
2
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
| 2019 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 08 | Day |
Last modified on
| 2020 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024865
