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)

JRCT ID: jRCT2063200014

Registered date:23/09/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Decompensated liver cirrhosis
• Date of first enrollment: 01/09/2020
• Target sample size: 10
• Study type: Interventional
• Intervention(s): The investigational product (LS-ABMSC1) will be infused into the liver via hepatic artery through the catheter.

Outcome(s)

• Primary Outcome: The number and incidence of adverse events with hepatic arterial infusion of the investigational product (LS-ABMSC1) until 24weeks after treatment.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include 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

Exclude 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 principle investigators or sub-investigators.

Related Information

• Primary Sponsor: Takami Taro
• Source(s) of Monetary Support: Shibuya Corporation,Japan Agency for Medical Research and Development (AMED)
• Secondary ID(s): UMIN000041461