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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041461
Receipt No. R000047329
Scientific Title An open-label, uncontrolled study to evaluate the efficacy and safety of autologous bone marrow mesenchymal stem cells (LS-ABMSC1) in patients with decompensated liver cirrhosis (Phase I / II study)
Date of disclosure of the study information 2020/08/31
Last modified on 2020/09/23

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Basic information
Public title An open-label, uncontrolled study to evaluate the efficacy and safety of autologous bone marrow mesenchymal stem cells (LS-ABMSC1) in patients with decompensated liver cirrhosis (Phase I / II study)
Acronym Study on the efficacy and safety of autologous bone marrow mesenchymal stem cells (LS-ABMSC1) in patients with decompensated liver cirrhosis
Scientific Title An open-label, uncontrolled study to evaluate the efficacy and safety of autologous bone marrow mesenchymal stem cells (LS-ABMSC1) in patients with decompensated liver cirrhosis (Phase I / II study)
Scientific Title:Acronym Study on the efficacy and safety of autologous bone marrow mesenchymal stem cells (LS-ABMSC1) in patients with decompensated liver cirrhosis
Region
Japan

Condition
Condition Decompensated liver cirrhosis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Primary purpose is to assess the safety of hepatic artery infusion of autologous bone marrow mesenchymal stem cells in patients with decompensated liver cirrhosis. Secondary purpose is to assess the efficacy on liver fibrosis and liver function.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes The number and incidence of adverse events with hepatic arterial infusion of the investigational product (LS-ABMSC1) until 24weeks after treatment.
Key secondary outcomes For following parameters, the value at each evaluation point up to 24 weeks after treatment (or at the time of discontinuation of the study) as well as the amount of change from baseline to each evaluation point.

1. Child-Pugh score
2. MELD-Na score
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 No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The investigational product (LS-ABMSC1) will be infused into the liver via hepatic artery through the catheter.
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 have the will and ability to provide consent form to participate in this clinical trial.
(2) Age: 20 to 75 years.
(3) Patients with liver cirrhosis confirmed by any of the following examinations
a. Liver biopsy
b. Imaging examination (abdominal ultrasound or CT examination or MRI examination), or FibroScan with result more than 12.5 kPa
(4) Child-Pugh score must be 7-12 points at 2 measurement points with 90 days or more interval.
(5) For female patients of childbearing potential, urine pregnancy test must be negative prior to study entry.
(6) Female patients of childbearing potential and male patients who have sex with fertile women must agree to use contraceptive method specified in the protocol.
(7) Patients must have the will and ability to visit hospital for examination at the time specified in the protocol
Key exclusion criteria (1) Patients with a current history of malignant neoplasm (active neoplasm or recurrence within 1 year).
However, carcinoma in situ or intramucosal cancer cured by local treatment are not included in active malignant neoplasms.
(2) Patients with gastroesophageal varices at risk of rupture.
(3) In patients with liver cirrhosis due to alcohol, alcohol consumption within 6 months before obtaining consent.
(4) Hemoglobin <8 g/dL, platelet count <50,000/uL at screening.
(5) Patients with hemorrhagic symptoms.
(6) Patients with renal dysfunction (serum creatinine greater than or equal to 2 mg/dL) at screening.
(7) Patients unable to obtain consent to allogeneic blood transfusion.
(8) Infection with syphilis, HIV (human immunodeficiency virus), adult T-cell leukemia virus, and parvovirus B19 cannot be denied.
(9) Women who have hope of pregnancy, or pregnant/lactating woman.
(10) Inability to collect bone marrow fluid.
(11) Inability to conduct abdominal angiography.
(12) Inability to conduct local and venous anesthesia.
(13) Patients with current or previous severe allergic reaction to any of the following.
Contrast agents, DMSO, HES, heparin, gentamicin, human serum albumin, bovine and porcine derived components.
(14) Administration of any of the following agents within 30 days before obtaining consent.
- Albumin, warfarin, vitamin K, fresh frozen plasma
(15) Change in the usage/dose of any of the following agents within 30 days before obtaining consent.
- Branched-chain amino acid, diuretics, zinc preparation, carnitine, synthetic disaccharides, antibiotics for the treatment of hepatic encephalopathy
(16) Conducted any of the following therapies within 30 days before obtaining consent.
- Ascites puncture, CART, peritoneal-venous shunt (Denver shunt)
(17) Patients who participate in other clinical trials, and patients who previously participated in this trial.
(18) Any other patients judged to be inappropriate for study inclusion by investigators.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Isao
Middle name
Last name Sakaida
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Gastroenterology & Hepatology
Zip code 755-8505
Address 1-1-1 Minami-Kogushi, Ube-city, Yamaguchi, Japan
TEL 0836-22-2241
Email sakaida@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name Taro
Middle name
Last name Takami
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 755-8505
Address 1-1-1 Minami-Kogushi, Ube-city, Yamaguchi, Japan
TEL 0836-22-2241
Homepage URL
Email t-takami@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization Yamaguchi University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) - Shibuya Corporation
- Japan Agency for Medical Research and Development (AMED)

IRB Contact (For public release)
Organization Institutional Review Board Yamaguchi University Hospital
Address 1-1-1 Minami-Kogushi, Ube-city, Yamaguchi, Japan
Tel 0836-22-2428
Email me223@yamaguchi-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 jRCT2063200014
Org. issuing International ID_1 Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 山口大学医学部附属病院(山口県)

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 31 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 Open public recruiting
Date of protocol fixation
2020 Year 06 Month 05 Day
Date of IRB
2020 Year 06 Month 26 Day
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2023 Year 02 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 19 Day
Last modified on
2020 Year 09 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047329

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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