UMIN-CTR Clinical Trial

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
Institute	Yamaguchi University Hospital
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040478