UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041461 |
|---|---|
| Receipt number | 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 | 2025/03/03 17:54:02 |
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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 | Taro |
| Middle name | |
| Last name | Takami |
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
t-takami@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
t-takami@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Taro Takami
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
Department of Gastroenterology, Kanazawa University Hospital
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
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)、金沢大学附属病院(石川県)
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
| 2025 | Year | 08 | Month | 31 | 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
| 2025 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047329
