Ulcerative Colitis
Conditions
Keywords
Cellsorba EX
Brief summary
This is a prospective, randomized, double-blind, sham treatment controlled multicenter study.
Interventions
DEVICECellsorba EX
conduct treatment twice a week for 3 weeks and once a week for 4 weeks, total 10 times
Sponsors
Asahi Kasei Medical Europe GmbH
Asahi Kasei Medical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed to have UC in the active stage based on clinical symptoms and findings from endoscopy * Patients with pancolitis type or left-sided colitis type lesion of 15 cm or longer observed endoscopically * Patients with Mayo score between 5 and 10 * Patients with Mayo sub-score (findings from flexible sigmoidoscopy) of 2 or 3 * Patients not having received any corticosteroids (referred to as steroids) (p.o., i.v., enema, suppository) within the past 6 weeks
Exclusion criteria
* Patients with a difficulty in peripheral vascular access * Patients having received ACE inhibitor (at least 10 times of its half-life time for interval needed before initiating the treatment) * Patients with toxic megacolon * Patients with a malignant disease or its experience * Patients with a severe cardiovascular disease (grade III or IV by the Classification of heart functions of the New York Heart Association (NYHA)) * Patients with a liver or kidney disease (AST(GOT) or ALT(GPT) or total bilirubin or creatinine level which is 2 or more times higher than the upper limit of normal (abbreviated as ULN, hereinafter) * Patients suspected to have or having HBV or HCV or HIV or pathogenic bacteria * Patients on anticoagulant therapy or with abnormality in the blood coagulation system (PT or PTT levels which are 1.5 or more times higher than ULN * Pregnant women or patients with possible pregnancy * Breast feeding women * Patients weighing 40 kg or less * Patients with hemoglobin level of less than 6.5 mmol/L (10.5 g/dL) * Patients with platelet count of less than 150 x 103/mm3, 150 x 109/L (15 x 104/mm3) * Patients with white blood cell count of less than 3.5 x 109/L (3,500/mm3) * Patients with hypotension (with systolic blood pressure of 80 mmHg or less)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response | at 8th week |
Secondary
| Measure | Time frame |
|---|---|
| Remission, Mayo scores, Mucosal healing, CRP | at 8th and 16th week |
Countries
Czechia, Germany, Israel, Japan, Sweden, United Kingdom
Outcome results
None listed