title: Randomized placebo-controlled trial of mesenchymal stem cell transplantation in decompensated cirrhosis.
abstract: OBJECTIVE
  There has been great interest in recent years to take advantage of bone marrow stem cells to treat cirrhosis. Our uncontrolled trial showed promising results for bone marrow mesenchymal stem cell (MSC) transplantation in cirrhosis. Therefore, we conducted a randomized, placebo-controlled trial to evaluate the efficacy of autologous MSC transplantation in cirrhosis.
  
  
  METHODS
  The enrolled patients with decompensated cirrhosis were randomly assigned to receive MSC or placebo infusions. A median of 195 million (range: 120-295 million) cultured MSCs were infused through a peripheral vein. The primary outcome was absolute changes in MELD score. Secondary outcomes were absolute changes in Child score, liver function tests and liver volumes between the MSC and placebo group 12 months after infusion.
  
  
  RESULTS
  A total of 27 patients were enrolled. Of these, 15 patients received MSC and 12 patients received placebo. One patient in the MSC group and one patient in the placebo group were lost to follow-up. Three patients in the MSC group died of liver failure 3 months (one patient), or 5 months (two patients) after cellular infusion. The baseline MELD scores of the deceased patients were significantly higher than those who remained alive in either group (20.0 vs. 15.1; P = 0.02). The absolute changes in Child scores, MELD scores, serum albumin, INR, serum transaminases and liver volumes did not differ significantly between the MSC and placebo groups at 12 months of follow-up.
  
  
  CONCLUSIONS
  Based on this randomized controlled trial, autologous bone marrow MSC transplantation through peripheral vein probably has no beneficial effect in cirrhotic patients. Further studies with higher number of patients are warranted to better clarify the impact of MSC infusion through peripheral vein or portal vein in cirrhosis.
authors.affiliation: Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Mehdi
authors.initials: M
authors.lastname: Mohamadnejad
authors.forename: Kamran
authors.initials: K
authors.lastname: Alimoghaddam
authors.forename: Mohammad
authors.initials: M
authors.lastname: Bagheri
authors.forename: Mandana
authors.initials: M
authors.lastname: Ashrafi
authors.forename: Leila
authors.initials: L
authors.lastname: Abdollahzadeh
authors.forename: Shahram
authors.initials: S
authors.lastname: Akhlaghpoor
authors.forename: Maryam
authors.initials: M
authors.lastname: Bashtar
authors.forename: Ardeshir
authors.initials: A
authors.lastname: Ghavamzadeh
authors.forename: Reza
authors.initials: R
authors.lastname: Malekzadeh
mesh_terms: D000328:Adult; D001663:Bilirubin / Q000097:blood; D001854:Bone Marrow Cells / Q000166:cytology*; D003404:Creatinine / Q000097:blood; D005260:Female; D006801:Humans; D008103:Liver Cirrhosis / Q000628:therapy*; D008111:Liver Function Tests; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000379:methods*; D008875:Middle Aged; D011446:Prospective Studies; D011517:Prothrombin Time; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D003404:Creatinine; D001663:Bilirubin
keywords: cirrhosis; stem cell; transplantation