NCT04088058招募中2 期
Adipose-Derived Stem Cells (ADSCs) Injections for Liver Cirrhosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from Baseline to Week 48 in The METAVIR score
研究概览
简要总结
The aim of the investigators study was to investigate the safety and efficacy of autologous ADSCs for the clinical treatment of liver cirrhosis.
详细描述
One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •Barrier methods of contraception: condom OR occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- •Female subject with childbearing potential who is pregnant (confirmed by urine or serum pregnancy test) or lactating
- •Having participated other investigational study within 4 weeks of entering this study
- •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
- •With drug dependency for the past 1 year of Screening visit
- •With any rare diseases
- •With uncontrolled hypertension (≥180/≥110 mmHg on more than 2 antihypertensive medications) or uncontrolled diabetic mellitus (HbA1c > 9.0%)
- •With liver abscess or moderate to severe (or refractory) ascites
- •With uncontrolled psychiatric disorder or altered mental status precluding informed consent or necessary testing
- •Having received major surgery within past 12 weeks of Screening visit
研究组 & 干预措施
GXHPC1
Experimental
One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.
干预措施: GXHPC1 (Drug)
结局指标
主要结局
Change from Baseline to Week 48 in The METAVIR score
时间窗: 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
次要结局
- 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)
研究者
研究点 (2)
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