Clinical Trial Study About Human Adipose-Derived Stem Cells in the Liver Cirrhosis

The aim of the investigators study was to investigate the safety and efficacy of autologous ADSCs for the clinical treatment of liver cirrhosis.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

China Medical University Beigang Hospital, Taichung, Beigang, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Liver cirrhosis investigators with age 20 to 80 years (both inclusive).
Investigators without Mandatory Communicable Disease (HBV, HCV, HIV, syphilis)
Investigators without rare disorder
Coagulation normalities
Investigators without autoimmune disorder
Investigators without Acquired Immune Deficiency Syndrome
Investigators without cancer
Investigators BMI > 15

Exclusion criteria

Pregnant women
Investigators with acute stroke in one month and unconsciousness
Investigators with acute myocardial infarction or acute heart failure
Investigators with serious liver dysfunction and coagulation dysfunction and ascites mild higher
Investigators with acute respiratory failure or pneumonia
Kidney Failure: BUN > 50
Anemia: Hematocrit < 25
Investigators diagnosed with liver cancer or liver metastatic carcinoma
Investigators with liver abscess
Investigators with acute Hepatitis
Investigators with acute infective
Liver cirrhosis patients with HBV or HCV
Investigators diagnosed with carcinoma and receiving treatment
Investigators with Schizophrenia or melancholia
Investigators received serious surgical operations in 3 months
Investigators unable to control hypertension (SBP > 180 mmHg, DBP > 110 mmHg) or diabetes (AC sugar > 200 mg/dl)
Others can't fit into the trial evaluate by investigator

Treatment and study plan

ADSCs

Drug

autologous ADSCs

Other names: hADSCs

Primary outcomes

MELD

Time frame: 1-6 month

MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. It is calculated according to the following formula:MELD = 3.78[Ln serum bilirubin (mg/dL)] + 11.2[Ln INR] + 9.57[Ln serum creatinine (mg/dL)] + 6.43.

Sponsors and collaborators

Lead sponsor

Gwo Xi Stem Cell Applied Technology Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2018
First posted: Nov 21, 2014
Registry last updated: Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed