Event reported in a literature article: journal of pediatric hematology/oncology 2014; 00:000-000.Accepted for publication october 3, 2014.'safety and outcomes of extracorporeal photopheresis with the therakos cellex system for graft-versus-host-disease in pediatric pts".An (b)(6) year old boy, one of four pts (all four with liver involvement) in a retrospective review of twelve pediatric pts that failed to respond to the treatment and died of multi-organ failure, no steroid tapering.Hsct indication: mds, myelodysplastic syndrome.Donor: mud, matched unrelated donor ((b)(6)).Stem cell: bm, bone marrow.Onset of gvhd (wk): gvhd treatment (pre-ecp): csa (cyclosporine), tacr (tacrolimus), mmf (mycophenolate mofetil), mp (methylprednisolone), atg (antithymocyte globulin).Interval between onset of gvhd and ecp (wk): gvhd type: acute (biopsy proven).Affected organs (stage in agvhd, score in cgvhd): skin (3), gis gastrointestinal (4), liver (3).Degree of gvhd: grade 3 acute gvhd.Improvement: no improvement.Ecp procedures: gvhd treatment during ecp: tacr, mp.Beginning of improvement (if any) (number of procedures): - survival: expired.Current status: died of multi-organ failure, no steroid tapering.Date of death was not reported.
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No lot number was reported; therefore, no batch record review was performed.There were no trends detected for complaint categories, death or multi-organ failure.An (b)(6) year old with grade 3 acute gvhd of mds died of multi-organ failure.Pt only had 4 ecp treatments.This case is serious and not related to ecp therapy.Therakos is reporting this out of an abundance of caution.(b)(4).
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