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

NCT04088058 | Unknown Phase 2

• 1 other identifier: GXHPC1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline to Week 48 in The METAVIR score

  The METAVIR score is a tool used to evaluate the severity of fibrosis seen on a liver biopsy sample. The METAVIR score grades the degree of fibrosis on a 5-point scale from 0 to 4 as follows: F0: No fibrosis F1: Portal fibrosis without septa F2: Portal fibrosis with few septa F3: Numerous septa without cirrhosis F4: Cirrhosis

  48 weeks

Secondary Outcomes (6)

• Change from Baseline to Week 24 in The METAVIR score

  24 weeks

• Change from baseline to Weeks 24, and 48 in Fibroscan® score for liver elasticity

  24 weeks, 48 weeks

• Change from baseline to Weeks 12, 24, 36, and 48 in the MELD score

  12 weeks, 24 weeks, 36 weeks, 48 weeks

• Change from baseline to Weeks 12, 24, 36, and 48 in the Child-Pugh score

  12 weeks, 24 weeks, 36 weeks, 48 weeks

• Incidence of adverse event(AE) and SAE

  0-48 weeks

Study Arms (1)

GXHPC1

EXPERIMENTAL

One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.

Drug: GXHPC1

Interventions

GXHPC1 DRUG

autologous ADSCs

Also known as: hADSCs

GXHPC1

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Of either gender aged 20 to 70 years old (inclusive) 2. Diagnosed liver cirrhosis by CT 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.
• \. 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.
• \. Provision of signed and dated informed consent form

You may not qualify if:

• With inadequate coagulation function, as defined by: INR ≥ 1.5, aPTT ≥ 54.0 seconds, platelet count ≤ 50,000/mm3.
• Note: INR = international normalized ratio, aPTT = activated partial thromboplastin time 2. With evidence of active autoimmune disease 3. With a medical record of malignancy within 5 years prior to screening, excluding curatively treated basal cell skin cancer, squamous cell skin cancer and carcinoma in situ of any site except urinary bladder.
• \. With BMI ≤ 15 kg/m2 Note: BMI = body mass index 5. With inadequate hepatic function, as defined by: total bilirubin level \> 5.0 mg/dL; AST \> 3 × ULN, ALT \> 3 × ULN, γ-GT \> 4 × ULN, or ALP \> 3 × ULN Note: γ-GT = Gamma-glutamyltransferase 6. With inadequate renal function, as defined by serum creatinine \> 2.0 mg/dL 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:
• Established use of oral, injected or implanted hormonal methods of contraception
• Placement of an intrauterine device (IUD) or intrauterine system (IUS)
• 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.
• \. 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

Sponsors & Collaborators

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

Study Sites (2)

HualienTzu Chi Hospital

Hualien City, 700, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei County, 10048, Taiwan

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Huang ka Wen, Director

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Lee Mi Che, Director

  Hualien Tzu Chi General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huang Pi Chun

CONTACT

+886-3-6580768; sabrina@gwoxi.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 12, 2019
• Study Start: November 16, 2019
• Primary Completion: April 19, 2025
• Study Completion: April 19, 2025
• Last Updated: April 10, 2023

Record last verified: 2023-04

Locations

TW (2)