ADR-001-N1

JRCT ID: jRCT2033210425

Registered date:12/11/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Compensated liver cirrhosis (Child-Pugh A)
• Date of first enrollment: 08/02/2022
• Target sample size: 9
• Study type: Interventional
• Intervention(s): A fixed dose of ADR-001 (1.0 x 108 cells/patient) will be administered once a week for four weeks in repeated doses. The interval between each administration will be at least six days, and a total of four administration will be performed within 42 days from the first administration.

Outcome(s)

• Primary Outcome: The amount of change in Albumin-bilirubin (ALBI) score

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Men and Women >= 20 years old of age on the date of consent.
2) Patient with cirrhosis any of the following criteria.
F4 cirrhotic patients diagnosed by previous liver biopsy.
F4 cirrhotic patients diagnosed by MR elastography.
F4 cirrhotic patients diagnosed by ultrasound elastography.
3) Patients with cirrhosis any of the following criteria.
Alcoholic steatohepatitis, abstaining from alcohol for more than 6 months.
Non-alcoholic steatohepatitis, on exercise and diet therapy for more than 6 month.
Chronic hepatitis B, with negative for HBV-DNA for at least 6 months after a treatment with nucleic acid analogues.
Past Chronic hepatitis C, attained a sustained virological response by antiviral therapy for more than 12 months.
4) Child-Pugh score: 6 points or less.
5) Patients capable of giving written informed consent.

Exclude criteria

1) Malignancy (except relapse-free survival >5 years).
2) Gastroesophageal varices to treat.
3) History of venous thrombosis or pulmonary embolism.
4) A neutrophil count below the lower limit of the reference.
5) D-dimer level >=3.0 microgram/mL or FDP level >= 15 microgram/mL
6) Serum creatinine level >= 2.0 mg/dL
7) Serum total-bilirubin level >= 5.0 mg/dL
8) Patients experienced transplantation or cell therapy, previously.
9) Pregnancy, lactation, or desire to have children in study period.
10) Severe cardiovascular, renal, or respiratory disease.
11) Alcoholic liver cirrhosis patients with The Alcohol Use Disorders Identification Test (AUDIT) >=8 points.
12) Inadequate physical condition, as diagnosed by their physician.

Related Information

• Primary Sponsor: Terai Shuji
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development