81 BACTERIAL INFECTIONS, ENDOTOXEMIA AND SYSTEMIC INFLAMMATION IN CIRRHOSIS ARE ASSOCIATED WITH AN IMBALANCE OF VON WILLEBRAND FACTOR (VWF) AND ITS CLEAVING PROTEASE ADAMTS13

Abstract

patient received 3 times infusion every the fourth day, with a follow-up for 52 weeks. The criteria for Adverse Event (AE) was mainly in accordance to the NCI-CTCAE 4.0 version. The study got an approval from IRB, and all subjects have signed ICF before study enrollment (ClinicalTrials.gov identifier: NCT01342250). Results: 20 patients were recruited (14 male and six female, mean age 54.2±5.9 years) from Nov 2010 to May 2011. 17 of them were diagnosed as HBV, while one was HCV. All patients were tolerant with the infusion. Two patients died for complications after 6 months of the first infusion. The overall survival rate was 90% at week 52. The most common AEs were fever, neutrophilia, hyperammonemia, hyperbilirubinemia, and prolonged prothrombin time (PT). Only one SAE (prolonged PT) might be related to cells infusion according to the investigator’s assessment, but the patient recovered soon, and survives well until now. The occurrence rate of AE doesn’t increase with cell dose escalation. Meanwhile, the mean level of pre-albumin almost doubled after 12 months, and increased from 74.55 to 104.61 g/L (P < 0.01). Total protein, albumin (P < 0.05). The Child–Turcotte–Pugh (CTP) score and SF-36 questionnaire were also improved significantly at 6 and 12 months (P < 0.05). Until now, no tumor occurrence was detected during 18 months after the first infusion. Conclusions: It is safe and tolerant when the cells dose escalated to 2x10 cells/per infusion for DLC patients on the dose limiting toxicity (DLT) test. The study suggests that hUCMSCs could improve clinical outcomes at 52 weeks of follow-up for these patients. And we will initiate a series of muti-center, randomized, blinded studies to explore the safety and efficacy further.