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.
adipose tissue dissociation device
adipose tissue-derived regenerative (stem) cells
investigator-initiated clinical trial protocol
liver
liver cirrhosis
protocol
stem cell therapy
stem cells
stromal cells
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
31 Mar 2020
31 Mar 2020
Historique:
received:
20
01
2020
accepted:
11
03
2020
revised:
02
03
2020
entrez:
2
4
2020
pubmed:
2
4
2020
medline:
2
4
2020
Statut:
epublish
Résumé
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. 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. 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. 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. 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. UMIN Clinical Trials Registry UMIN000022601; https://tinyurl.com/w9uqw3q. DERR1-10.2196/17904.
Sections du résumé
BACKGROUND
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
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
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
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
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
BACKGROUND
UMIN Clinical Trials Registry UMIN000022601; https://tinyurl.com/w9uqw3q.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
DERR1-10.2196/17904.
Identifiants
pubmed: 32229470
pii: v9i3e17904
doi: 10.2196/17904
pmc: PMC7319609
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e17904Informations de copyright
©Yoshio Sakai, Shinya Fukunishi, Masayuki Takamura, Oto Inoue, Shinichiro Takashima, Soichiro Usui, Akihiro Seki, Alessandro Nasti, Tuyen Thuy Bich Ho, Kazunori Kawaguchi, Akira Asai, Yusuke Tsuchimoto, Taro Yamashita, Tatsuya Yamashita, Eishiro Mizukoshi, Masao Honda, Yasuhito Imai, Kenichi Yoshimura, Toshinori Murayama, Takashi Wada, Kenichi Harada, Kazuhide Higuchi, Shuichi Kaneko. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 31.03.2020.
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