An Follow-Up Study of Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
This is a follow-up study to assess safety and preliminary clinical activity of ADR-001 in patients with liver cirrhosis (Child-Pugh score; Grade B) caused by Hepatitis C or Nonalcoholic Steatohepatitis. Patients who have already participated in the ADR-001-01 study and completed the last evaluation after 24 weeks of administration will be eligible to this study. Patients registered will continue follow-up observation and evaluate long-term safety and exploratory efficacy.

Official Title
-----------------
An Observational Follow-Up Study of Patients Previously Enrolled in ADR-001-01 Study Against Liver Cirrhosis

Conditions
-----------------
Decompensated Liver Cirrhosis

Intervention / Treatment
-----------------
* Drug: Mesenchymal Stem Cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver cirrhosis patients enrolled in ADR-001-01 study and completed the last observation of the study Voluntary signed informed consent Exclusion Criteria: Patients evaluated by investigators as inappropriate

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mesenchymal Stem Cell|As this is a follow-up and an observation study, ADR-001 was administered in the previous study, not in this study.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events (AEs) and serious AEs (SAEs) | An AE is any untoward medical event for the patient in the clinical study, associated with study medication. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of hospitalization, results in disability/incapacity, congenital anomaly/birth defect will be evaluated as an SAE. | Change from Baseline (Day 0) until 80 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of liver function evaluated by Child-Pugh Score | Change of liver function from the baseline will be evaluated by Child-Pugh score. | Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks) | 
| Improvement rate of Child-Pugh score | Improvement rate of Child-Pugh score from the baseline will be evaluated. | Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks) | 
| Improvement rate of Child-Pugh grade | Improvement rate of Child-Pugh grade from the baseline will be evaluated. | Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks) | 
| Number of patients with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP) findings | SBP and DBP will be measured at specific time points (mmHg) | Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks) | 
| Number of patients with abnormal pulse rate findings | Pulse rate will be measured at specific time points (bit per minutes). | Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks) | 
| Number of patients with abnormal body temperature findings | Axillary temperature will be measured at specific time points. (degree Celsius) | Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks) | 
| Number of patients with abnormal electrocardiogram (ECG) findings | 12-lead ECG will be obtained at specific time points. | Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks) | 
| Number of patients with abnormal clinical chemistry parameters | Laboratory assessment for clinical chemistry parameters will include blood total protein, albumin, total and direct bilirubin, aspartate aminotransferase, alanine aminotransferase, r-glutamyltranspeptidase, alkaline phosphatase, cholinesterase, lactate dehydrogenase, uric acid, blood urea nitrogen, ammonia, serum creatinine, sodium, potassium, chlorine, calcium, phosphate, magnesium, C reactive protein creatinine, glucose, | Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks) | 
| Number of patients with abnormal clinical hematology parameters | Laboratory assessment for clinical hematology will include white blood cell, red blood cell, hemoglobin, hematocrit, platelet, reticulocytes, neutrophils, lymphocytes, eosinophils, basophils, monocytes | Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks) | 
| Number of patients with abnormal urinalysis parameters | Laboratory assessment for urinalysis will include glucose, protein and occult blood | Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks) |