A Phase II Open-label Single-arm Study to Evaluate the Efficacy and Safety of ADSCs in Subjects With Liver Cirrhosis

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the investigators study was to investigate the safety and efficacy of autologous ADSCs for the clinical treatment of liver cirrhosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gwo Xi Stem Cell Applied Technology Co., Ltd.

Criteria

Inclusion Criteria:

1. Of either gender aged 20 to 70 years old (inclusive)

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

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; gamma-GT > 212.5 U/L, or ALP > 340 U/L.

Note: gamma-GT = gamma glutamyl transpeptidase

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:

1. Established use of oral, injected or implanted hormonal methods of contraception

2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)

3. 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 infectious disease except HBV or HCV 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