UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022601 |
|---|---|
| Receipt number | R000026052 |
| Scientific Title | Open-label and uncontrolled clinical trial by multicenter for liver regenerative therapy for liver cirrhosis using autologous subcutaneous adipose tissue-derived regenerative(stem) cells to assess efficacy and safety |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2021/06/08 14:56:25 |
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Basic information
Public title
Open-label and uncontrolled clinical trial by multicenter for liver regenerative therapy for liver cirrhosis using autologous subcutaneous adipose tissue-derived regenerative(stem) cells to assess efficacy and safety
Acronym
Clinical trial of liver regenerative therapy using autologous adipose tissue-derived regenerative cells
Scientific Title
Open-label and uncontrolled clinical trial by multicenter for liver regenerative therapy for liver cirrhosis using autologous subcutaneous adipose tissue-derived regenerative(stem) cells to assess efficacy and safety
Scientific Title:Acronym
Clinical trial of liver regenerative therapy using autologous adipose tissue-derived regenerative cells
Region
| Japan |
Condition
Condition
liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of efficacy and safety of autologous adipose tissue-derived regenerative (stem) cell therapy delivered to the liver via hepatic artery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
serum albumin concentration, prothrombin activity, harmful event, malfunction
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
intrahepatic arterial administration of autologous adipose tissue derived regenerative (stem) cells (3.3x10^5 cells/Kg)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Criteria defined in the clinical trial implementation protocol
Key exclusion criteria
Criteria defined in the clinical trial implementation protocol
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Kaneko |
Organization
Kanazawa University
Division name
College of Medical, Pharmaceutical and Health Sciences
Zip code
9208641
Address
13-1 Takara-machi, Kanazawa, JAPAN
TEL
076-265-2235
skaneko@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | Yoshio |
| Middle name | |
| Last name | Sakai |
Organization
Kanazawa University
Division name
College of Medical, Pharmaceutical and Health Sciences
Zip code
9208641
Address
13-1 Takara-machi, Kanazawa, JAPAN
TEL
076-265-2235
Homepage URL
yoshios@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Medical University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Innovative Clinical Research Center, Kanazawa University
Address
13-1 Takara-machi, Kanazawa
Tel
076-265-2090
irb@adm.kanazawa-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
金沢大学附属病院、大阪医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.researchprotocols.org/2020/3/e17904/authors
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2352320421000316
Number of participants that the trial has enrolled
8
Results
registration terminated
Results date posted
| 2020 | Year | 06 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 04 | Month | 27 | Day |
Baseline Characteristics
published in Renerative Therapy 2021 vo.18 p.97-101
Participant flow
published in Renerative Therapy 2021 vo.18 p.97-101
Adverse events
published in Renerative Therapy 2021 vo.18 p.97-101
Outcome measures
published in Renerative Therapy 2021 vo.18 p.97-101
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 04 | Day |
Last modified on
| 2021 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026052
| 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 |
