Adipose-Derived Stem Cells (ADSCs) Injections for Liver Cirrhosis

Gwo Xi Stem Cell Applied Technology Co., Ltd.2 sites in 1 country20 target enrollmentNovember 16, 2019

ConditionsLiver Cirrhosis

InterventionsGXHPC1

DrugsGXHPC1

Overview

Phase: Phase 2
Intervention: GXHPC1
Conditions: Liver Cirrhosis
Sponsor: Gwo Xi Stem Cell Applied Technology Co., Ltd.
Enrollment: 20
Locations: 2
Primary Endpoint: Change from Baseline to Week 48 in The METAVIR score
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 16, 2019

End Date

April 19, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Gwo Xi Stem Cell Applied Technology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Of either gender aged 20 to 70 years old (inclusive)
•Diagnosed liver cirrhosis by CT imaging, irrespective of etiology
•With MELD score 10 to 20 (inclusive) and Child-Pugh score 7 to 9 Note: MELD = Model For End-Stage Liver Disease
•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
•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

Exclusion Criteria

•With inadequate coagulation function, as defined by: INR ≥ 1.5, aPTT ≥ 54.0 seconds, platelet count ≤ 50,000/mm
•Note: INR = international normalized ratio, aPTT = activated partial thromboplastin time
•With evidence of active autoimmune disease
•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
•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
•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)

Arms & Interventions

GXHPC1

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

Intervention: GXHPC1

Outcomes

Primary Outcomes

Change from Baseline to Week 48 in The METAVIR score

Time Frame: 48 weeks

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

Secondary Outcomes

Change from baseline to Weeks 24, and 48 in Fibroscan® score for liver elasticity(24 weeks, 48 weeks)
Change from Baseline to Week 24 in The METAVIR score(24 weeks)
Change from baseline to Weeks 12, 24, 36, and 48 in the MELD score(12 weeks, 24 weeks, 36 weeks, 48 weeks)
Incidence of adverse event(AE) and SAE(0-48 weeks)
Incidence of serious adverse event (SAE)(0-48 weeks)
Change from baseline to Weeks 12, 24, 36, and 48 in the Child-Pugh score(12 weeks, 24 weeks, 36 weeks, 48 weeks)