Clinical trial NCT04088058: A Phase II Open-label Single-arm Study to Evaluate the Efficacy and Safety of ADSCs in Subjects With Liver Cirrhosis
Official title: Adipose-Derived Stem Cells (ADSCs) Injections for Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Cirrhosis
Lead sponsor: Gwo Xi Stem Cell Applied Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline to Week 48 in The METAVIR score
timeFrame: 48 weeks
Secondary outcomes:
measure: Change from Baseline to Week 24 in The METAVIR score
timeFrame: 24 weeks
measure: Change from baseline to Weeks 24, and 48 in Fibroscan® score for liver elasticity
timeFrame: 24 weeks, 48 weeks
measure: Change from baseline to Weeks 12, 24, 36, and 48 in the MELD score
timeFrame: 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Change from baseline to Weeks 12, 24, 36, and 48 in the Child-Pugh score
timeFrame: 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Incidence of adverse event(AE) and SAE
timeFrame: 0-48 weeks
measure: Incidence of serious adverse event (SAE)
timeFrame: 0-48 weeks
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: HualienTzu Chi Hospital
city: Taipei county
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Huang ka Wen, Director
role: PRINCIPAL_INVESTIGATOR
affiliation: Hualien Tzu Chi General Hospital
name: Lee Mi Che, Director
role: PRINCIPAL_INVESTIGATOR
References: