Allogeneic clonal mesenchymal stem cell therapy for refractory graft-versus-host disease to standard treatment: a phase I study

The Korean Journal of Physiology & Pharmacology : Official Journal of the Korean Physiological Society and the Korean Society of Pharmacology
Hyeon Gyu YiSun U Song

Abstract

Severe graft-versus-host disease (GVHD) is an often lethal complication of allogeneic hematopoietic stem cell transplantation (HSCT). The safety of clinical-grade mesenchymal stem cells (MSCs) has been validated, but mixed results have been obtained due to heterogeneity of the MSCs. In this phase I study, the safety of bone marrow-derived homogeneous clonal MSCs (cMSCs) isolated by a new subfractionation culturing method was evaluated. cMSCs were produced in a GMP facility and intravenously administered to patients who had refractory GVHD to standard treatment resulting after allogeneic HSCT for hematologic malignancies. After administration of a single dose (1×10(6) cells/kg), 11 patients were evaluated for cMSC treatment safety and efficacy. During the trial, nine patients had 85 total adverse events and the rate of serious adverse events was 27.3% (3/11 patients). The only one adverse drug reaction related to cMSC administration was grade 2 myalgia in one patient. Treatment response was observed in four patients: one with acute GVHD (partial response) and three with chronic GVHD. The other chronic patients maintained stable disease during the observation period. This study demonstrates single cMSC infusion to have an accepta...Continue Reading

References

May 13, 2008·Lancet·Katarina Le BlancUNKNOWN Developmental Committee of the European Group for Blood and Marrow Transplantation
Sep 4, 2009·Cytotherapy·Minoo Battiwalla, Peiman Hematti
Jun 2, 2010·International Journal of Hematology·Joo Han LimSun U Song
Dec 21, 2011·International Journal of Hematology·Richard HerrmannPaul Cannell
Apr 19, 2012·Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation·Paul J MartinPaul A Carpenter
Aug 21, 2012·Annals of the New York Academy of Sciences·Maria Ester Bernardo, Willem E Fibbe
Dec 10, 2013·Therapeutic Advances in Hematology·Catherine GarnettJiří Pavlů

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Citations

Jan 24, 2017·Journal of Tissue Engineering and Regenerative Medicine·Moonhang KimByung Hyune Choi
Aug 1, 2018·Frontiers of Medicine·Shihua WangRobert Chunhua Zhao
Feb 24, 2020·Stem Cell Reviews and Reports·Bernardo ZoehlerMaria Da Graça Bicalho

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