Safety Assessment of Autologous Stem Cell Combination Therapy in Patients With Decompensated Liver Cirrhosis: A Pilot Study

Haematopoietic stem cell (HSC) infusion has demonstrated short-term improvement in liver functions in patients with chronic liver disease. The combination of HSC with mesenchymal stem cells (MSCs), which has an immunomodulatory effect, may augment the effects and enhance the duration of improvements...

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Published in:	Journal of clinical and experimental hepatology Vol. 12; no. 1; pp. 80 - 88
Main Authors:	Sharma, Mithun, Pondugala, Pavan K., Jaggaihgari, Shashidhar, Mitnala, Sasikala, Krishna, Vemula V., Jaishetwar, Ganesh, Naik, Pragati, Kumar, Pramod, Kulkarni, Anand, Gupta, Rajesh, Singh, Jagdeesh R., Darisetty, Santosh, Sekharan, Anuradha, Reddy, Duvurr N., Rao, Guduru V., Syeda, Fatima, Jagtap, Nitin, Rao, Padaki N.
Format:	Journal Article
Language:	English
Published:	India Elsevier B.V 01-01-2022 Elsevier
Subjects:	cirrhosis of liver combination of stem cells mesenchymal stem cells Original stem cells cirrhosis of liver cath-lab stem cells combination of stem cells CBA IL MNC USG TJLB AFP G-CSF 7-AAD MELD SOP mesenchymal stem cells FBS HSC CLD MSC DMEM-KO CLD, chronic liver disease MNC, mononuclear cell AFP, alpha-fetoprotein SOP, standard operating procedure cath-lab, cardiac catheterization laboratory DMEM-KO, Dulbecco's modified Eagle's Knock out medium 7-AAD, 7-aminoactinomycin D G-CSF, granulocyte colony-stimulating factor HSC, haematopoietic stem cell MELD, Model for End-Stage Liver Disease IL, interleukin CBA, cytokine cytometric bead assay FBS, foetal bovine serum USG, ultrasonography TJLB, transjugular liver biopsy MSC, mesenchymal stem cell
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Summary:	Haematopoietic stem cell (HSC) infusion has demonstrated short-term improvement in liver functions in patients with chronic liver disease. The combination of HSC with mesenchymal stem cells (MSCs), which has an immunomodulatory effect, may augment the effects and enhance the duration of improvements on liver functions. The aim of the present study was to assess the safety of infusing the combination of autologous HSCs and MSCs in decompensated liver cirrhosis. In phase I of the study, in vitro assessment was performed to observe the effect of coculturing MSCs with HSCs on their viability and cytokine profiles. Phase II of the study was to assess the safety of combination of stem cell infusions. Bone marrow (50 ml) was aspirated for MSC isolation and expansion using standard protocol. Patients received subcutaneous doses (n = 5) of granulocyte colony-stimulating factor (G-CSF) for stem cell mobilization followed by leukapheresis for harvesting HSCs using CliniMacs. HSCs and MSCs were infused through the hepatic artery under fluoroscopic guidance and were monitored for any adverse effects. In vitro studies revealed 94% viable HSCs in coculture similar to monoculture. HSCs released only interleukin (IL)-8, whereas MSCs secreted IL-8 and IL-6 in monocultures, and both IL-8 and IL-6 were secreted in coculture. G-CSF administration– and bone marrow aspiration–related complications were not observed. Infusion of the cells through the hepatic artery was safe, and no postprocedural complications were noted. The combination of autologous HSC and MSC infusion is a safe procedure in patients with decompensated liver cirrhosis, and the outcomes needed to be assessed in larger studies. NCT04243681.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0973-6883 2213-3453
DOI:	10.1016/j.jceh.2021.03.010