Abstract
BackgroundLiver cirrhosis results from chronic hepatitis, and is characterized by advanced fibrosis due to long-term hepatic inflammation. Cirrhosis ultimately leads to manifestations of jaundice, ascites, and encephalopathy, and increases the risk of hepatocellular carcinoma. Once cirrhosis is established, resulting in hepatic failure, no effective treatment is available. Therefore, novel therapies to inhibit disease progression of cirrhosis are needed.ObjectiveThe objective of this investigator-initiated clinical trial is to assess the safety and efficacy of autologous adipose tissue-derived regenerative (stem) cell therapy delivered to the liver via the hepatic artery in patients with liver cirrhosis.MethodsThrough consultation with the Japan Pharmaceuticals and Medical Devices Agency, we designed a clinical trial to assess a therapy for liver cirrhosis based on autologous adipose tissue-derived regenerative (stem) cells, which are extracted using an adipose tissue dissociation device. The primary endpoints of the trial are the serum albumin concentration, prothrombin activity, harmful events, and device malfunction.ResultsEnrollment and registration were initiated in November 2017, and the follow-up period ended in November 2019. Data analysis and the clinical study report will be completed by the end of March 2020.ConclusionsCompletion of this clinical trial, including data analysis, will provide data on the safety and efficacy of this novel liver repair therapy based on autologous adipose tissue-derived regenerative (stem) cells using an adipose tissue dissociation device.Trial RegistrationUMIN Clinical Trials Registry UMIN000022601; https://tinyurl.com/w9uqw3qInternational Registered Report Identifier (IRRID)DERR1-10.2196/17904
Highlights
BackgroundLiver cirrhosis is the eventual outcome of chronic liver diseases, including chronic hepatitis, autoimmune hepatitis, primary biliary cholangitis, alcoholic hepatitis, and nonalcoholic steatohepatitis (NASH), which is currently increasing in prevalence relative to other liver conditions and is associated with metabolic disease [1,2]
Through consultation with the Japan Pharmaceuticals and Medical Devices Agency, we designed a clinical trial to assess a therapy for liver cirrhosis based on autologous adipose tissue-derived regenerative cells, which are extracted using an adipose tissue dissociation device
Data analysis and the clinical study report will be completed by the end of March 2020. Completion of this clinical trial, including data analysis, will provide data on the safety and efficacy of this novel liver repair therapy based on autologous adipose tissue-derived regenerative cells using an adipose tissue dissociation device
Summary
BackgroundLiver cirrhosis is the eventual outcome of chronic liver diseases, including chronic hepatitis, autoimmune hepatitis, primary biliary cholangitis, alcoholic hepatitis, and nonalcoholic steatohepatitis (NASH), which is currently increasing in prevalence relative to other liver conditions and is associated with metabolic disease [1,2]. Liver cirrhosis leads to various complications, including esophageal varix, hepatic encephalopathy, ascites, jaundice, and hepatocellular carcinoma, which result in a worse prognosis for patients with cirrhosis [3]. The end stage of cirrhosis is hepatic failure, for which liver transplantation is the only treatment as an extremely invasive procedure that requires continuous immunosuppressive therapy for the remainder of the patient’s life. Steatohepatitis is strongly correlated with metabolic syndrome, it is not clear why steatosis of the liver causes chronic inflammation and leads to cirrhosis [5]. Liver cirrhosis results from chronic hepatitis, and is characterized by advanced fibrosis due to long-term hepatic inflammation. Cirrhosis leads to manifestations of jaundice, ascites, and encephalopathy, and increases the risk of hepatocellular carcinoma. Once cirrhosis is established, resulting in hepatic failure, no effective treatment is available. Novel therapies to inhibit disease progression of cirrhosis are needed
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