The aim of the investigators study was to investigate the safety and efficacy of autologous ADSCs for the clinical treatment of liver cirrhosis.
One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
autologous ADSCs
HualienTzu Chi Hospital
Hualien City, Taiwan
RECRUITINGNational Taiwan University Hospital
Taipei County, Taiwan
RECRUITINGChange from Baseline to Week 48 in The METAVIR score
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
Time frame: 48 weeks
Change from Baseline to Week 24 in The METAVIR score
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
Time frame: 24 weeks
Change from baseline to Weeks 24, and 48 in Fibroscan® score for liver elasticity
Fibroscan® is a non-invasive modality to measure elasticity of liver tissue. A fibroscan® score is a numerical result between 2-75. A 'normal' Fibroscan range tends to be between 2-7 with an average result being roughly around 5. Scarring of the liver is measured by four stages. F0 = no scarring F1 = mild fibrosis F2 = moderate fibrosis F3 = severe fibrosis F4 = cirrhosis or advanced fibrosis
Time frame: 24 weeks, 48 weeks
Change from baseline to Weeks 12, 24, 36, and 48 in the MELD score
The Model for End-Stage Liver Disease, or MELD, is a scoring system for assessing the severity of the chronic liver disease. MELD score is calculated according to the subject's values for serum total bilirubin, serum creatinine, and INR.
Time frame: 12 weeks, 24 weeks, 36 weeks, 48 weeks
Change from baseline to Weeks 12, 24, 36, and 48 in the Child-Pugh score
The Child-Pugh score is used to assess the prognosis of chronic liver disease, mainly cirrhosis. The score employs five clinical measures of liver disease. Each measure is scored 1-3, with 3 indicating most severe derangement.
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Time frame: 12 weeks, 24 weeks, 36 weeks, 48 weeks
Incidence of adverse event(AE) and SAE
An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not relate with the medicinal (investigational) product.
Time frame: 0-48 weeks
Incidence of serious adverse event (SAE)
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes (based on ICH GCP): * results in death, * is life-threatening, * requires inpatient hospitalization or prolongation of existing hospitalization, * results in persistent or significant disability/incapacity, or * is a congenital anomaly/birth defect
Time frame: 0-48 weeks