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NCT Number: NCT03254758

A Study of ADR-001 in Patients With Liver Cirrhosis

This is a first-in-human Phase1/2 study of ADR-001, adipose-derived mesenchymal stem cells (AD-MSCs). The safety and preliminary efficacy are evaluated in Phase 1 in patients with liver cirrhosis caused by Hepatitis C or Nonalcoholic Steatohepatitis and a recommended Phase 2 dose is determined by the evaluation. The exploratory efficacy and safety are investigated against the same target population in Phase 2.

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Key information

Conditions

Decompensated Liver Cirrhosis

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Niigata University Medical & Dental Hospital, Niigata, Japan

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About this study

Patients with decompensated liver cirrhosis (Child-Pugh score; Grade B) caused by Hepatitis C or Nonalcoholic Steatohepatitis are enrolled to the study. In Phase 1, one of 3 doses of AD-MSCs is administered by 1 hour single intravenous infusion. Patients are hospitalized for 1 week and a recommended dose for Phase 2 is determined by the evaluation of the safety and efficacy. In Phase 2, patients with the same disease criteria are enrolled and dosed to investigate the exploratory efficacy and safety.

The safety and efficacy are evaluated until 24 weeks after dosing both in Phase 1 and Phase 2.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women ≥ 20 years of age
  • Chronic hepatitis C or nonalcoholic steatohepatitis(NASH)
  • Child-Pugh grade B liver cirrhosis
  • ECOG Performance Status ≤ 2

Exclusion criteria

  • Liver cirrhosis patients other than hepatitis C or NASH
  • Malignant neoplasm (except hepatocellular carcinoma patients without recurrence more than 2 years)
  • History of venous thrombosis or pulmonary embolism
  • Serum creatinine ≥ 2 mg/dL or T-Bil ≥ 5.0 mg/dL
  • Infection with hepatitis B, HIV, ATLV-1 or parvovirus B19
  • Patients experienced transplantation or cell therapy
  • Pregnancy or positive on pregnancy test
  • Complications of significant heart disease, kidney disorder, or respiratory disease
  • Drug or alcohol abuse

Treatment and study plan

Mesenchymal stem cell

Biological

Phase1 The dose of AD-MSCs are escalated from low to mid and high step by step. Each administration is one time via intravenous infusion for one hour.

Phase2 The recommended dose of ADR-001 is administrated once a week 4 times. The administration route and time is same method with Phase 1.

Primary outcomes

  1. Safety profile of ADR-001 including the incidence of adverse events (Phase 1)

    Time frame: 24 weeks

    Safety will be evaluated based on the medical review of adverse event reports and the results of clinical laboratory tests, vital sign, and physical examinations.

  2. Improvement rate of Child-Pugh score (Phase 2)

    Time frame: 24 weeks

    Improvement rate of Child-Pugh score from the baseline will be evaluated.

Secondary outcomes

  1. Change of liver function evaluated by Child-Pugh score (Phase 1)

    Time frame: 24 weeks

    Change of liver function from the baseline will be evaluated by Child-Pugh score.

  2. Improvement rate of Child-Pugh score (Phase 1)

    Time frame: 24 weeks

    Improvement rate of Child-Pugh score from the baseline will be evaluated.

  3. Improvement rate of Child-Pugh grade (Phase 1)

    Time frame: 24 weeks

    Improvement rate of Child-Pugh grade from the baseline will be evaluated.

  4. Change of liver function evaluated by Child-Pugh score (Phase 2)

    Time frame: 24 weeks

    Change of liver function from the baseline will be evaluated by Child-Pugh score.

  5. Improvement rate of Child-Pugh grade (Phase 2)

    Time frame: 24 weeks

    Improvement rate of Child-Pugh grade from the baseline will be evaluated.

  6. Safety profile of ADR-001 including the incidence of adverse events (Phase 2)

    Time frame: 24 weeks

    Safety will be evaluated based on the medical review of adverse event reports and the results of clinical laboratory tests, vital sign, and physical examinations.

Sponsors and collaborators

Lead sponsor

Rohto Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase 1/2 Study of ADR-001 in Patients With Liver Cirrhosis

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Aug 18, 2017
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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