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A Study of ADR-001 in Patients With Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT03254758
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Decompensated Liver Cirrhosis Biological: Mesenchymal stem cell Phase 1 Phase 2

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of ADR-001 in Patients With Liver Cirrhosis
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Mesenchymal stem cell
Single dose of ADR-001 (Mesenchymal stem cell)
Biological: Mesenchymal stem cell
Single dose of ADR-001, mesenchymal stem cells, is administered by intravenous 1 hour infusion.


Outcome Measures

Primary Outcome Measures :
  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. 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.


Secondary Outcome Measures :
  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. Improvement rate of Child-Pugh score (Phase 2) [ Time Frame: 24 weeks ]
    Improvement rate of Child-Pugh score from the baseline will be evaluated.

  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.


Eligibility Criteria

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254758


Contacts
Contact: Rohto Pharmaceutical Co., Ltd. +81-3-6823-6014 adr-001@rohto.co.jp

Locations
Japan
Niigata University Medical & Dental Hospital Recruiting
Niigata, Japan, 951-8510
Contact: Division of Gastroenterology and Hepatology    +81-3-6823-6014    adr-001@rohto.co.jp   
Sponsors and Collaborators
Rohto Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Shuji Terai, MD Niigata University Medical & Dental Hospital
More Information

Responsible Party: Rohto Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03254758     History of Changes
Other Study ID Numbers: ADR-001-01
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases