A Phase II Open-label Single-arm Study to Evaluate the Efficacy and Safety of ADSCs in Subjects With Liver Cirrhosis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GXHPC1 One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle. |
Drug: GXHPC1
autologous ADSCs
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Neurological function [6 month]
The net change on NIHSS at each evaluation time point
Eligibility Criteria
Criteria
Inclusion Criteria:
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Of either gender aged 20 to 70 years old (inclusive)
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Diagnosed liver cirrhosis by imaging, irrespective of etiology
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With MELD score 10 to 20 (inclusive) and Child-Pugh score 7 to 9 Note: MELD = Model For End-Stage Liver Disease
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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.
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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
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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.
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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 ≤ 60,000/mm3.
Note: INR = international normalized ratio, aPTT = activated partial thromboplastin time
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With evidence of active autoimmune disease
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With a medical record of solid tumor within 5 years prior to screening, or diagnosed with solid tumor and currently receiving cancer treatment
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With BMI ≤ 15 kg/m2 Note: BMI = body mass index
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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
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With inadequate renal function, as defined by serum creatinine > 2.0 mg/dL
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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:
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Established use of oral, injected or implanted hormonal methods of contraception
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Placement of an intrauterine device (IUD) or intrauterine system (IUS)
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Barrier methods of contraception: condom OR occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
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Female subject with childbearing potential who is pregnant (confirmed by urine or serum pregnancy test) or lactating
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Having participated other investigational study within 4 weeks of entering this study
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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.
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With ongoing infection requiring systemic treatment such as HIV, syphilis or acute infectious disease except HBV or HCV Note: HIV = human immunodeficiency virus
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With drug dependency for the past 1 year of Screening visit
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With any rare diseases
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With uncontrolled hypertension (≥180/≥110 mmHg on more than 2 antihypertensive medications) or uncontrolled diabetic mellitus (HbA1c > 9.0%)
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With liver abscess or moderate to severe (or refractory) ascites
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With uncontrolled psychiatric disorder or altered mental status precluding informed consent or necessary testing
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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
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With acute stroke within past 4 weeks of Screening visit and being unclear consciousness
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With acute myocardial infarction or acute heart failure
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Has uncontrolled ongoing illness or medical history considered by the investigator not in the condition to enter the trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | HualienTzu Chi Hospital | Hualien City | Taiwan | 700 | |
| 2 | National Taiwan University Hospital | Taipei county | Taiwan | 10048 |
Sponsors and Collaborators
- Gwo Xi Stem Cell Applied Technology Co., Ltd.
Investigators
- Principal Investigator: Huang ka Wen, Director, National Taiwan University Hospital
- Principal Investigator: Lee Mi Che, Director, Hualien Tzu Chi General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GXHPC1