REpeated AutoLogous Infusions of STem cells In Cirrhosis (REALISTIC): a multicentre, phase II, open-label, randomised controlled trial of repeated autologous infusions of granulocyte colony-stimulating factor (GCSF) mobilised CD133+ bone marrow stem cells in patients with cirrhosis. A study protocol for a randomised controlled trial

BMJ Open
A KingP N Newsome

Abstract

Liver disease mortality and morbidity are rapidly rising and liver transplantation is limited by organ availability. Small scale human studies have shown that stem cell therapy is safe and feasible and has suggested clinical benefit. No published studies have yet examined the effect of stem cell therapy in a randomised controlled trial and evaluated the effect of repeated therapy. Patients with liver cirrhosis will be randomised to one of three trial groups: group 1: Control group, Standard conservative management; group 2 treatment: granulocyte colony-stimulating factor (G-CSF; lenograstim) 15 µg/kg body weight daily on days 1-5; group 3 treatment: G-CSF 15 µg/kg body weight daily on days 1-5 followed by leukapheresis, isolation and aliquoting of CD133+ cells. Patients will receive an infusion of freshly isolated CD133+ cells immediately and frozen doses at days 30 and 60 via peripheral vein (0.2×10(6) cells/kg for each of the three doses). Primary objective is to demonstrate an improvement in the severity of liver disease over 3 months using either G-CSF alone or G-CSF followed by repeated infusions of haematopoietic stem cells compared with standard conservative management. The trial is powered to answer two hypotheses of ea...Continue Reading

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Citations

Oct 3, 2015·Digestive and Liver Disease : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver·Pietro AndreoneRoberto M Lemoli
Feb 26, 2016·Cellular & Molecular Immunology·Cynthia Ju, Frank Tacke
Nov 1, 2016·Stem Cells International·Paula MüllerRobert David
Mar 21, 2017·Nature Reviews. Immunology·Oliver Krenkel, Frank Tacke
Feb 18, 2017·BioMed Research International·Irina V Kholodenko, Konstantin N Yarygin
Apr 20, 2018·Canadian Journal of Gastroenterology & Hepatology·Kyeong-Ah KwakYoung-Seok Park
Dec 27, 2017·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Nipun VermaVirendra Singh
Aug 21, 2019·Cells·Antonella GiancottiVincenzo Cardinale
Oct 5, 2019·Current Medicinal Chemistry·Anjum MahmoodAnand S Srivastava

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Methods Mentioned

BETA
biopsy
PCR
contraception
pregnancy test
leukapheresis
X-ray
ELISA
flow cytometry

Software Mentioned

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