Single Infusion of Donor Mononuclear Early Apoptotic Cells as Prophylaxis for Graft- versus-Host Disease in Myeloablative HLA-Matched Allogeneic Bone Marrow.

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Single Infusion of Donor Mononuclear Early Apoptotic Cells as Prophylaxis for Graft- versus-Host Disease in Myeloablative HLA-Matched Allogeneic Bone Marrow Transplantation: A Phase I/IIa Clinical Trial Dror Mevorach, Tsila Zuckerman, Inna Reiner, Avichai Shimoni, Simcha Samuel, Arnon Nagler, Jacob M. Rowe, Reuven Or Biology of Blood and Marrow Transplantation Volume 20, Issue 1, Pages 58-65 (January 2014) DOI: 10.1016/j.bbmt.2013.10.010 Copyright © 2014 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 1 Potency assays. ApoCell potency was assessed using flow cytometric evaluation of DR and the costimulatory molecule CD86 on dendritic cells (DCs) after exposure to lipopolysaccharide (LPS), as explained in the methods section. Immature DCs express a low level of HLA-DR and costimulatory molecule CD86 (green lines). After exposure to maturation stimuli, LPS, immature DCs undergo maturation and upregulate expression levels of HLA- DR and costimulatory molecule CD86 (red lines). Interaction with ApoCell at 1:2, 1:4, and 1:8, DCs: ApoCell ratios 2 hours before LPS exposure inhibits LPS induced HLA-DR and CD86 upregulation (blue lines). A representative sample from 13 ApoCell preparations infused to the patients (summarized in Table 2). Biology of Blood and Marrow Transplantation 2014 20, 58-65DOI: (10.1016/j.bbmt.2013.10.010) Copyright © 2014 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 2 Clinical course of aGVHD. Cohort 1 (3 patients), 2 (4 patients), 3 (3 patients), and 4 (3 patients) are presented. Figure 2A shows total incidence of aGVHD grade II to IV by cohorts. Figure 2B shows total incidence of hepatotoxicity by cohorts. Figure 2C shows time to the first hospital discharge by cohorts. Time to first hospital discharge is defined as the time from the day of HSCT (day 0) to the day of first hospital discharge. Biology of Blood and Marrow Transplantation 2014 20, 58-65DOI: (10.1016/j.bbmt.2013.10.010) Copyright © 2014 American Society for Blood and Marrow Transplantation Terms and Conditions