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

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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

Email

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


Email

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

Email

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


Research Plan
Registered date File name
2019/03/08 提供する再生医療等の詳細.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name