chronic liver disease/Liver Cirrhosis

The primary objective is to evaluate the efficacy profile of GXHPC1 to treat liver cirrhosis subjects in terms of change from baseline to Week 48 in histopathologic assessments of liver biopsy for liver cirrhosis. The histopathologic assessments of liver biopsy for liver cirrhosis will be conducted in central laboratory and evaluated by independent histopathologist. The investigator will then determine the change from baseline based on the biopsy results

GXHPC1

Autologous Adipose-derived Stem Cells (ADSCs)

vial

1x10^8

Primary Endpoints:
Change from baseline to Week 48 in histopathologic assessments of
liver biopsy for liver cirrhosis

Main inclusion criteria:
1. Of either gender aged 20 to 70 years old (inclusive)
Note: In Taiwan, age of majority recognized in law is 20 years of age. Subject aged 18-20 years old intending
to participate in clinical study requires his/her parents or guardians to give consent.
2. Diagnosed liver cirrhosis by imaging irrespective of etiology
3. With MELD score 10 to 20 (inclusive) and Child-Pugh score 7 to 9
Note: MELD = Model For End-Stage Liver Disease
4. Subject with alcoholic cirrhosis should have been alcohol‐abstinent for at least 6
months judged by psychiatrist with records for each month and willing to continue up to
the completion of study.
5. Subject with cirrhosis caused by hepatitis B virus (HBV) should be with HBV DNA <
2,000 IU/mL before enrollment.
Note: HBV = hepatitis B virus, DNA = deoxyribonucleic acid. IU = International unit
6. Subject with cirrhosis caused by hepatitis C virus (HCV) should have successfully
completed treatment for HCV with HCV viral load in the blood undetectable for at least
24 weeks since treatment cessation and with ALT within normal range.
7. Provision of signed and dated informed consent form

Main exclusion criteria:
1. With inadequate coagulation function, as defined by: INR ≥ 1.5, aPTT ≥ 54.0 seconds,
platelet count ≤ 60,000/mm3
.
Note: INR = international normalized ratio, aPTT = activated partial thromboplastin time
2. With evidence of active autoimmune disease
3. With a medical record of solid tumor within 5 years prior to screening, or diagnosed with
solid tumor and currently receiving cancer treatment
4. With BMI ≤ 15 kg/m2
Note: BMI = body mass index
5. With inadequate hepatic function, as defined by: total bilirubin level > 3.0 mg/dL; AST >
92.5 U/L, ALT > 112.5 U/L; -GT > 212.5 U/L, or ALP > 340 U/L.
6. With inadequate renal function, as defined by serum creatinine > 2.0 mg/dL
7. The subject refuses to adopt highly effective contraceptives from signing informed consent
to Final visit if female subject or female spouse/partner of male subject is of childbearing
potential
Note: At least two forms of birth control must be adopted and one of which must be a barrier method.
Acceptable forms of birth control include:
a. Established use of oral, injected or implanted hormonal methods of contraception
b. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
c. Barrier methods of contraception: condom OR occlusive cap (diaphragm or cervical/vault caps) with
spermicidal foam/gel/film/cream/suppository
8. Female subject with childbearing potential who is pregnant (confirmed by urine or serum
pregnancy test) or lactating
9. Having participated other investigational study within 4 weeks of entering this study
10. Has a known allergy to study intervention or its excipients. If there is suspicion that the
subject may have an allergy, the subject should be excluded.
11. With ongoing infection requiring systemic treatment such as HIV, syphilis or acute
inflectional disease
Note: HIV = human immunodeficiency virus
12. With drug dependency for the past 1 year of Screening visit
13. With any rare diseases
14. With uncontrolled hypertension (≥180/≥110 mmHg on more than 2 antihypertensive
medications) or uncontrolled diabetic mellitus (HbA1c > 9.0%)
15. With liver abscess or moderate to severe (or refractory) ascites
16. With uncontrolled psychiatric disorder or altered mental status precluding informed
consent or necessary testing
17. Having received major surgery within past 12 weeks of Screening visit
Note: Major surgery means an operation upon an organ within the cranium, chest, abdomen, or pelvic cavity
18. With acute stroke within past 4 weeks of Screening visit and being unclear consciousness
19. With acute myocardial infarction or acute heart failure
20. Has uncontrolled ongoing illness or medical history considered by the investigator not in
the condition to enter the trial