Efficacy Study of Granulocytapheresis Plus Steroids vs Steroids Alone in Active Steroid Dependant Ulcerative Colitis

Exclusion Criteria

• •Febrile (\> 38ºC)
• •Evidence of toxic megacolon
• •Anticipated need for surgery within 24 weeks
• •Known obstructive diseases of the gastrointestinal system
• •Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis
• •A history of allergic reaction to heparin or heparin-induced thrombocytopenia
• •A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures
• •Requires a central venous access catheter for the apheresis treatments
• •Known infection with enteric pathogens, pathogenic ova or parasites, C. difficile toxin or CMV
• •Hypotension (systolic blood pressure \<80 mmHg and/or diastolic blood pressure \<50 mmHg) at screening visit only
• •Uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>120 mmHg) despite medical therapy
• •A history of myocardial infarction or unstable angina within the past 6 months
• •A history of coronary artery bypass grafting surgery or angioplasty within the past 6 months
• •Prosthetic heart valve, pacemaker or other permanent implant
• •Severe cardiovascular or peripheral vascular disease, severe renal disease
• •Liver disease defined as levels of SGOT \[AST\], SGPT \[ALT\] or alkaline phosphatase \>2.5x the upper limit of the normal range for the laboratory performing test
• •History of cirrhosis
• •Known bleeding disorder (PT or PTT\>1.5x the upper limit of the normal range for the laboratory performing the test), or concomitant anticoagulant therapy for purposes other than apheresis treatment
• •Prior history suggestive of a hypercoagulable disorder, including 1 or more episodes of pulmonary embolism or deep vein thrombosis
• •Known infection with Hepatitis B or C, or HIV
• •Abnormal hematology parameters defined as severe anemia with hemoglobin \<8.5g/dL, white blood cell count of \<3,500/μl and a granulocyte count \< 2,000/μl
• •Fibrinogen level \>700mg/dL
• •Major surgery within the past 6 months
• •Infection:Active infections less than 4 weeks from successful completion of antibiotic treatment for routine bacterial infectionFebrile viral infection within 4 weeks of entry into the clinical investigationLess than 12 weeks from conclusion of therapy for systemic fungal infections
• •Malignancy within the past 2 years other than surgically cured skin carcinoma or cervical dysplasia (CIN I-II)
• •History of dysplasia or carcinoma of the colon or lack of a complete colonoscopy in the last 12 months in patients with longstanding UC (\> 10 años)
• •Current drug or alcohol abuse
• •Pregnant, lactating or planning to become pregnant during the course of the clinical investigation
• •Used within the last 30 days an investigational drug, biologic or device or 5 half-lifes, if known, for any investigational drug or biologic
• •Received cyclosporine or tacrolimus within the last 8 weeks
• •Received infliximab within the last 8 weeks
• •Fulminant ulcerative colitis