Reinfusion of highly purified CD133+ bone marrow-derived stem/progenitor cells in patients with end-stage liver disease: A phase I clinical trial

Pietro Andreone, Lucia Catani, Cristina Margini, Lucia Brodosi, Stefania Lorenzini, Daria Sollazzo, Benedetta Nicolini, Rosaria Giordano, Tiziana Montemurro, Simonetta Rizzi, Elisa Dan, Valeria Giudice, Mariele Viganò, Andrea Casadei, Francesco G. Foschi, Deborah Malvi, Mauro Bernardi, Fabio Conti, Roberto M. Lemoli

Research output: Contribution to journalArticle

Abstract

Background: Bone marrow stem/progenitor cells seem to be effective in liver regeneration after tissue injury. Aim: To evaluate the feasibility and safety of the mobilization and reinfusion of CD133+ stem/progenitor cells in patients with end-stage liver disease. Methods: Autologous CD133+ stem/progenitor cells, mobilized with granulocyte-colony stimulating factor, were collected by leukapheresis and reinfused at increasing doses through the hepatic artery starting from 5 × 104/kg up to 1 × 106/kg. Results: 16 subjects with Model for End-stage Liver Disease (MELD) score between 17 and 25 were enrolled, 14 mobilized an adequate number of CD133+ stem/progenitor cells and 12 were reinfused. No severe adverse events related to the procedure were reported. MELD score significantly worsened during mobilization in Child Turcotte Pugh-C patients. A significant improvement of liver function was observed 2 months after reinfusion (MELD 19.5 vs 16; P = 0.045). Overall, 5 patients underwent liver transplantation within 12 months from reinfusion and 2 died because of progressive liver failure. Conclusions: CD133+ stem/progenitor cells reinfusion in patients with end-stage liver disease is feasible and safe. A worsening of liver function was observed during mobilization in Child Turcotte Pugh-C patients. The temporary improvement of MELD score after reinfusion suggests that stem cells therapy may be a "bridge to transplant" approach for these patients.

Original languageEnglish
Pages (from-to)1059-1066
Number of pages8
JournalDigestive and Liver Disease
Volume47
Issue number12
DOIs
Publication statusPublished - Dec 1 2015

Keywords

  • Cirrhosis
  • Haematopoietic stem/progenitor cells
  • Regenerative medicine
  • Stem cell therapy

ASJC Scopus subject areas

  • Medicine(all)
  • Hepatology
  • Gastroenterology

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