TY  - JOUR
AU  - Sakai, Yoshio
AU  - Fukunishi, Shinya
AU  - Takamura, Masayuki
AU  - Inoue, Oto
AU  - Takashima, Shinichiro
AU  - Usui, Soichiro
AU  - Seki, Akihiro
AU  - Nasti, Alessandro
AU  - Ho, Tuyen Thuy Bich
AU  - Kawaguchi, Kazunori
AU  - Asai, Akira
AU  - Tsuchimoto, Yusuke
AU  - Yamashita, Taro
AU  - Yamashita, Tatsuya
AU  - Mizukoshi, Eishiro
AU  - Honda, Masao
AU  - Imai, Yasuhito
AU  - Yoshimura, Kenichi
AU  - Murayama, Toshinori
AU  - Wada, Takashi
AU  - Harada, Kenichi
AU  - Higuchi, Kazuhide
AU  - Kaneko, Shuichi
PY  - 2020
DA  - 2020/3/31
TI  - Regenerative Therapy for Liver Cirrhosis Based on Intrahepatic Arterial Infusion of Autologous Subcutaneous Adipose Tissue-Derived Regenerative (Stem) Cells: Protocol for a Confirmatory Multicenter Uncontrolled Clinical Trial
JO  - JMIR Res Protoc
SP  - e17904
VL  - 9
IS  - 3
KW  - adipose tissue-derived regenerative (stem) cells
KW  - stromal cells
KW  - stem cells
KW  - liver cirrhosis
KW  - investigator-initiated clinical trial protocol
KW  - adipose tissue dissociation device
KW  - protocol
KW  - stem cell therapy
KW  - liver
AB  - Background: Liver 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. Objective: The 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. Methods: 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 (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. Results: Enrollment 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. Conclusions: 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 (stem) cells using an adipose tissue dissociation device. Trial Registration: UMIN Clinical Trials Registry UMIN000022601; https://tinyurl.com/w9uqw3q International Registered Report Identifier (IRRID): DERR1-10.2196/17904 
SN  - 1929-0748
UR  - http://www.researchprotocols.org/2020/3/e17904/
UR  - https://doi.org/10.2196/17904
DO  - 10.2196/17904
ID  - info:doi/10.2196/17904
ER  -