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논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 저널정보
- 대한약리학회 The Korean Journal of Physiology & Pharmacology The Korean Journal of Physiology & Pharmacology 제20권 제1호
- 발행연도
- 2016.1
- 수록면
- 63 - 67 (5page)
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초록· 키워드
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Severe graft-versus-host disease (GVHD) is an often lethal complication of allogeneic hematopoietic stem cell transplantation (HSCT). The safety of clinicalgrade 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 (1×106 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 acceptable safety profile and promising efficacy, suggesting that we can proceed with the next stage of the clinical trial.
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등록된 정보가 없습니다.
참고문헌 (17)
참고문헌 신청
Garnett C / 2013 / Treatment and management of graft-versus-host disease : improving response and survival / Ther Adv Hematol 4:366~378
Martin PJ / 2012 / Secondary treatment of acute graft-versus-host disease : a critical review / Biol Blood Marrow Transplant 18:982~988
Sellar RS / 2012 / Recent progress in managing graft-versushost disease and viral infections following allogeneic stem cell transplantation / Future Oncol 8:1549~1565
Battiwalla M / 2009 / Mesenchymal stem cells in hematopoietic stem cell transplantation / Cytotherapy 11:503~515
Le Blanc K / 2008 / Mesenchymal stem cells for treatment of steroid-resistant, severe, acute graft-versus-host disease : a phase II study / Lancet 371:1579~1586
Martin PJ / 2012 / Secondary treatment of acute graft-versus-host disease : a critical review / Biol Blood Marrow Transplant 18:982~988
Sellar RS / 2012 / Recent progress in managing graft-versushost disease and viral infections following allogeneic stem cell transplantation / Future Oncol 8:1549~1565
Battiwalla M / 2009 / Mesenchymal stem cells in hematopoietic stem cell transplantation / Cytotherapy 11:503~515
Le Blanc K / 2008 / Mesenchymal stem cells for treatment of steroid-resistant, severe, acute graft-versus-host disease : a phase II study / Lancet 371:1579~1586
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