Status:
COMPLETED
A Study of ADR-001 in Patients With Liver Cirrhosis
Lead Sponsor:
Rohto Pharmaceutical Co., Ltd.
Conditions:
Decompensated Liver Cirrhosis
Eligibility:
All Genders
20+ years
Phase:
PHASE1
PHASE2
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 caus...
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 admini...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03254758
Start Date
July 20 2017
End Date
April 13 2023
Last Update
July 6 2023
Active Locations (2)
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1
Niigata University Medical & Dental Hospital
Niigata, Japan, 951-8510
2
Nihon University Itabashi Hospital
Tokyo, Japan, 173-8610