A Study of ADR-001 in Patients With Liver Cirrhosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-20

Study Completion Date

2023-04-13

Brief Summary

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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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Detailed Description

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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.

Conditions

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Decompensated Liver Cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mesenchymal stem cell

Phase 1 Dose escalation : low Mid High Single administalation of ADR-001

Phase 2 The recommended dose of ADR-001

Group Type EXPERIMENTAL

Mesenchymal stem cell

Intervention Type 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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No