TY - JOUR
T1 - Reinfusion of highly purified CD133+ bone marrow-derived stem/progenitor cells in patients with end-stage liver disease
T2 - A phase I clinical trial
AU - Andreone, Pietro
AU - Catani, Lucia
AU - Margini, Cristina
AU - Brodosi, Lucia
AU - Lorenzini, Stefania
AU - Sollazzo, Daria
AU - Nicolini, Benedetta
AU - Giordano, Rosaria
AU - Montemurro, Tiziana
AU - Rizzi, Simonetta
AU - Dan, Elisa
AU - Giudice, Valeria
AU - Viganò, Mariele
AU - Casadei, Andrea
AU - Foschi, Francesco G.
AU - Malvi, Deborah
AU - Bernardi, Mauro
AU - Conti, Fabio
AU - Lemoli, Roberto M.
PY - 2015/12/1
Y1 - 2015/12/1
N2 - 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.
AB - 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.
KW - Cirrhosis
KW - Haematopoietic stem/progenitor cells
KW - Regenerative medicine
KW - Stem cell therapy
UR - http://www.scopus.com/inward/record.url?scp=84983146118&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84983146118&partnerID=8YFLogxK
U2 - 10.1016/j.dld.2015.08.018
DO - 10.1016/j.dld.2015.08.018
M3 - Article
C2 - 26427587
AN - SCOPUS:84983146118
VL - 47
SP - 1059
EP - 1066
JO - Digestive and Liver Disease
JF - Digestive and Liver Disease
SN - 1590-8658
IS - 12
ER -