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

NCT ID: NCT04088058

Last Updated: 2023-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-16
• Study Completion Date: 2025-04-19

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.

Detailed Description

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

Conditions

Liver Cirrhosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GXHPC1

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

Group Type: EXPERIMENTAL

GXHPC1

Intervention Type: DRUG

autologous ADSCs

Interventions

GXHPC1

autologous ADSCs

Intervention Type: DRUG

Other Intervention Names

hADSCs

Eligibility Criteria

Inclusion Criteria

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.

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.

7. Provision of signed and dated informed consent form

Exclusion Criteria

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.

4. 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:

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gwo Xi Stem Cell Applied Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huang ka Wen, Director

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Lee Mi Che, Director

Role: PRINCIPAL_INVESTIGATOR

Hualien Tzu Chi General Hospital

Locations

HualienTzu Chi Hospital

Hualien City, , Taiwan

Site Status: RECRUITING

National Taiwan University Hospital

Taipei County, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Huang Pi Chun

Role: CONTACT

sabrina@gwoxi.com

+886-3-6580768 ext. 332

Facility Contacts

Lee Mi Che, Directer

Role: primary

Huang Ka Wen, Director

Role: primary

Other Identifiers

GXHPC1

Identifier Type: -

Identifier Source: org_study_id