Trial | NCT03254758  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    21
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.
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 Started
Jul 20
2017
Primary Completion
Apr 13
2023
Study Completion
Apr 13
2023
Last Update
Jul 06
2023

Biological Mesenchymal stem cell

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.

Mesenchymal stem cell Experimental

Phase 1 Dose escalation : low Mid High Single administalation of ADR-001 Phase 2 The recommended dose of ADR-001

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
No Results Posted