Safety and tolerability of a modified filter-type device for leukocytapheresis using ACD-A as anticoagulant in patients with mild to moderately active ulcerative colitis. Results of a pilot study.
Cellsorba™ is a medical device for leukocytapheresis (LCAP) treatment of ulcerative colitis (UC). Cellsorba™ EX Global type has been developed from Cellsorba E for intended use with ACD-A as anticoagulant. We evaluated safety and efficacy of the modified Cellsorba using ACD-A in a pilot trial comprising patients with active UC, despite receiving 5-ASA. A total of 10 LCAP treatments/patients were administered. Safety assessment focused on clinical signs and symptoms, hematological variables, as well as levels of bradykinin and IL-6. Efficacy was determined using the Mayo clinical/endoscopic scoring index as well histological assessment of biopsies. Additional aim was to evaluate the impact of apheresis system lines and filter on selected regulatory molecules. All six subjects completed the trial without any serious adverse events. WBC, platelet counts, and levels of bradykinin and IL-6 were not significantly affected. The median Mayo score decreased from 8.0 to 3.5 at week 8 (and to 2 at week 16 for the responders). Four patients were responders, of whom two patients went into remission. Median histological scores decreased from 3.5 to 2.0 in these four patients. Concentration of LL-37 increased within the apheresis system lines. LCAP with Cellsorba EX using ACD-A as anticoagulant was found to be a safe and well-tolerated procedure in patients with active UC. The positive impact on efficacy parameters merits further evaluation in a controlled fashion.
Muratov
Vladislaw
V
Unit of Clinical immunology, Department of Clinical Immunology and Transfusion Medicine, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden. vladislaw.muratov@karolinska.se
Lundahl
Joachim
J
Mandic-Havelka
Aleksandra
A
Elvin
Kerstin
K
Ost
Ake
A
Shizume
Yasumasa
Y
Furuya
Kaoru
K
Löfberg
Robert
R
D000293:Adolescent; D000328:Adult; D000925:Anticoagulants / Q000627:therapeutic use*; D023181:Antimicrobial Cationic Peptides / Q000097:blood; D053285:CD30 Ligand / Q000097:blood; D019343:Citric Acid / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000628:therapy*; D005260:Female; D005947:Glucose / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007937:Leukapheresis / Q000295:instrumentation*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012449:Safety; D054804:Cathelicidins
D000925:Anticoagulants; D023181:Antimicrobial Cationic Peptides; D053285:CD30 Ligand; C002113:acid citrate dextrose; D019343:Citric Acid; D005947:Glucose; D054804:Cathelicidins