UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000035528
Receipt number R000040478
Scientific Title Study on the safety of hepatic arterial infusion of cultured autologous bone marrow cells in patients with decompensated liver cirrhosis
Date of disclosure of the study information 2019/01/15
Last modified on 2022/07/16 10:00:02

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Basic information

Public title

Study on the safety of hepatic arterial infusion of cultured autologous bone marrow cells in patients with decompensated liver cirrhosis

Acronym

Study on the safety of liver regeneration therapy with hepatic arterial infusion of cultured autologous bone marrow cells

Scientific Title

Study on the safety of hepatic arterial infusion of cultured autologous bone marrow cells in patients with decompensated liver cirrhosis

Scientific Title:Acronym

Study on the safety of liver regeneration therapy with hepatic arterial infusion of cultured autologous bone marrow cells

Region

Japan


Condition

Condition

decompensated liver cirrhosis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the safety of invasive liver regeneration therapy with hepatic artery infusion of cultured autologous bone marrow cells in patients with decompensated cirrhosis.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

The incidence of adverse events with hepatic arterial infusion of cultured autologous bone marrow cells

Key secondary outcomes

(1) Child-Pugh score
(2) Serum albumin levels
(3) Serum fibrosis markers
(4) Liver stiffness
(5) Portal blood flow


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

Hepatic arterial infusion of cultured autologous bone marrow-derived mesenchymal stem cells

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Patients with decompensated liver cirrhosis with a Child-Pugh score of 7 or higher (Child-Pugh B) at two points separated by at least 90 days, in whom further improvement is not expected with current medical treatment.
(2) Patients aged 20 to 75 years.
(3) Patients from whom written consent for participation in this clinical study was obtained.

Key exclusion criteria

(1) Patients with a current history of malignant neoplasm.
(2) Patients with gastroesophageal varices at risk of rupture.

(5) Patients with a hemoglobin <8 g/dL, a platelet count <50,000/uL, or a prothrombin time <40%.
(6) Patients with renal insufficiency and a serum creatinine greater than or equal to 2 mg/dL.
(7) Patients with a performance status of 3 or 4.
(8) Patients who refuse to consent to allogeneic blood transfusion.
(10) Women who are pregnant.
(12) Patients with a current or previous severe allergic reaction to anesthesia.
(13) Patients with a current or previous severe allergic reaction to a contrast agent.
(14) Patients with a current or previous severe allergic reaction to beef, cow milk.
(15) Patients who had an experience with other cell therapy or other clinical study of cell therapy.
(17) Any patient deemed unsuitable for study inclusion by their attending physician.

Target sample size

5


Research contact person

Name of lead principal investigator

1st name Taro
Middle name
Last name Takami

Organization

Yamaguchi University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code

755-8505

Address

1-1-1 Minami-kogushi, Ube, Yamaguchi, Japan

TEL

+81836222241

Email

t-takami@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name Taro
Middle name
Last name Takami

Organization

Yamaguchi University

Division name

Department of Gastroenterology and Hepatology

Zip code

755-8505

Address

1-1-1 Minami-kogushi, Ube, Yamaguchi, Japan

TEL

+81836222241

Homepage URL


Email

t-takami@yamaguchi-u.ac.jp


Sponsor or person

Institute

Yamaguchi University Hospital

Institute

Department

Personal name



Funding Source

Organization

Yamaguchi Pref and self funding

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Yamaguchi University Hospital Certified Committee for Regenerative Medicine

Address

1-1-1 Minami-kogushi, Ube, Yamaguchi, Japan

Tel

0836-22-2428

Email

ysaisei@yamaguchi-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



Other administrative information

Date of disclosure of the study information

2019 Year 01 Month 15 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

2018 Year 01 Month 15 Day

Date of IRB

2018 Year 02 Month 19 Day

Anticipated trial start date

2018 Year 02 Month 19 Day

Last follow-up date

2021 Year 08 Month 19 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 01 Month 12 Day

Last modified on

2022 Year 07 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040478


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name