UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025582 |
|---|---|
| Receipt number | R000029436 |
| Scientific Title | The safety and efficacy of Autologous adipose tissue derived mesenchymal stem cell on cirrhotic patients |
| Date of disclosure of the study information | 2017/01/16 |
| Last modified on | 2020/03/11 04:20:39 |
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Basic information
Public title
The safety and efficacy of Autologous adipose tissue derived mesenchymal stem cell on cirrhotic patients
Acronym
aipose tissue derived mesenchymal stem cell therapy for hepatitis and cirrhosis
Scientific Title
The safety and efficacy of Autologous adipose tissue derived mesenchymal stem cell on cirrhotic patients
Scientific Title:Acronym
aipose tissue derived mesenchymal stem cell therapy for hepatitis and cirrhosis
Region
| Japan |
Condition
Condition
liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Emergency medicine |
| Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, there is increasing basic research of adipose derived mesencymal stem cel therapy for liver cirrhosis. This study is aimed to elucidate the safety and efficacy on liver cirrhosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Liver function(Child-pugh score), respiratory function, general status (performance status), Biochemistry data, Coagulation status)
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
| Other |
Interventions/Control_1
adipose derived mesenchymal stem cell infusion therapy
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
1.Cirrhosis is proven by CT and clinical status.
2.Over age of 20 years old.
3.the socre more thtan 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
G.The patient who primary investigator judged unsuitable
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Akahoshi |
Organization
Kaizuka hospital
Division name
Department of surgery
Zip code
812-0053
Address
hakozaki 7-7-27, Higashi-ku, Fukuoka
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
Surgery
Zip code
812-8582
Address
hakozaki 7-7-27, Higashi-ku, Fukuoka
TEL
0926426223
Homepage URL
tomohiko@surg2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kaizuka hospital
Institute
Department
Personal name
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
comittee of regenerative medicine, kurume chuo hospital
Address
Komorino 2-3-8, Kurume, Fukuoka, Japan
Tel
0942-35-1000
k-chuo@soleil.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
貝塚病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 16 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2020 | 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
| 2017 | Year | 01 | Month | 09 | 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=R000029436
